Current Trends in Pharmacy and Pharmaceutical Chemistry, 2024
The objective of this study is to evaluate the bioequivalence of generic sitagliptin tablets from... more The objective of this study is to evaluate the bioequivalence of generic sitagliptin tablets from different manufacturers using in-vitro dissolution study under biowaiver conditions through UV Spectroscopy, and compare them with the innovator brand. Materials and Methods: The dissolution media consisted of three different buffers with varying pH levels, including HCl Buffer pH 2.0, Phosphate Buffer pH 4.0, and Phosphate Buffer pH 7.2. The dissolution process was conducted using a USP type-2 dissolution apparatus with a 900 ml basket. The rotational speed of the paddle was set at 50 RPM, while maintaining a temperature of 37.5 • C +/-2 • C. Samples were collected at four different intervals as recommended by the USFDA, which were 15, 30, 45, and 60 minutes. Results: Validation parameters such as Accuracy, Precision, Linearity, LOD, and LOQ were assessed. The dissolution profiles exhibited no significant variability between different brands and within the same brand. Furthermore, the dissolution results of all tablet formulations, including the innovator brand, were analysed using the difference factor (f1) and similarity factor (f2). Conclusion: The findings from this study indicate that both generic brands of sitagliptin tablets meet the USFDA dissolution specifications and can be considered interchangeable. This is an Open Access (OA) journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
Exploration of targeted anti-tumor therapy, Aug 30, 2023
One of the major causes of death on the globe is cancer. The fourth most frequent malignancy in w... more One of the major causes of death on the globe is cancer. The fourth most frequent malignancy in women worldwide is cervical cancer. Several cancer patients are remaining incurable due to the emergence of medication resistance, despite notable advances in cancer research over the previous few decades. The importance of natural sources as possible therapeutic candidates may be significant. Anthraquinones are one of the many chemical families of natural products, and they stand out for their wide range of structural variations, notable biological activity, and low toxicity. A natural substance called emodin, an anthraquinone derivative, is present in the roots and rhizomes of several plants. This substance has demonstrated antineoplastic, antiinflammatory, antiangiogenic, and antiproliferative properties. It is also capable of preventing cancer spread and can reverse cancer cells' multidrug resistance. Emodin, a broad-spectrum inhibitor of cancer cells, have anticancer properties in many different types of biological pathways. These molecular mechanisms in cancer cells include the suppression of cell growth and proliferation, deterioration of the cell cycle arrest, the start of apoptosis, antimetastasis, and antiangiogenic impact. Therefore, the aim of the present review summarised the antiproliferative and anticarcinogenic qualities of cervical cancer of emodin.
In many areas of human life, including food, health, culture, and religion, mushrooms have had a ... more In many areas of human life, including food, health, culture, and religion, mushrooms have had a significant impact. Most people eat mushrooms for their flavor and texture. Recently, they have gained popularity as a protein source and a drug research tool. According to the phyla Ascomycota and Basidiomycota, mushrooms are fungi that produce spongy fruiting bodies, particularly those that possess a stalk and an envelope top. Mushrooms are composed of 90% water and 10% dry material. Additionally, it has a physicochemical composition that is important for nutrition. Edible mushrooms have been shown to offer therapeutic benefits, including anti-cancer, cardiovascular, hepatoprotective, neuroprotective, hypolipidemic, antiviral, antibacterial, and anti-diabetic actions. Mushrooms are a fantastic source of nourishment since they are rich in proteins, minerals, complex sugars, unsaturated fatty acids, and secondary metabolites. The composition and nutritional benefits of edible mushrooms have been carefully investigated in this review. Edible mushrooms have been used as potential therapeutic stand-ins, and bioactive components present in edible mushrooms, such as polyphenolic compounds and antioxidant activity, have also been studied. This review article may also help scientists, researchers, and medical professionals slow the advancement of some lifestyle diseases, neurological disorders, along autoimmune disorders.
International journal of pharmacy and technology, Mar 31, 2020
Microspheres are normally free flowing powders contains proteins or synthetic polymers which has ... more Microspheres are normally free flowing powders contains proteins or synthetic polymers which has biodegradable in nature and having a particle size but 200-500 μm. Number of techniques for the preparation of microspheres offers a spread of opportunities to regulate aspects of drug administration and enhance the therapeutic efficacy of a drug. A neat controlled drug delivery system can overcome a number of problems of conventional therapy and enhance therapeutic efficacy of the drug. There are various approaches in delivering therapeutic substance to the target site in sustained and controlled release fashion. These are prepared by methods like Single emulsion, Double emulsion, Polymerization, Phase separation coacervation, Emulsion solvent evaporation and solvent diffusion. Microspheres are having wide selection of applications due to controlled and sustained release.
American journal of pharmacy and health research, Oct 20, 2018
Standardization of herbal formulation is essential in order to check quality, purity, safety and ... more Standardization of herbal formulation is essential in order to check quality, purity, safety and efficacy of drug. "Swadisht Virechan" churna play an important role in constipation and detoxification due to safety and efficacy in it. Hence churna has been formulated by standard procedure and evaluated by organoleptic study, physical characteristics and physicochemical screening. One marketed formulation and one lab scale formulation were subjected to comparative standardization. The churna was standardized by determination of organoleptic characters, pH, loss on drying, ash value, extractive value, physical characteristics such as bulk density; tap density, angle of repose to determine flowability, determination of particle size, microbial content. The result of various parameters obtained from study showed that marketed formulation and lab scale formulation have comparable physical values. The flowability of formulation was found to be poor in both formulations. These studies showed that there is no uniformity in preparation of formulation which is may be due to varied geographical locations where there plants grow. The present paper reports the investigation and standardization of swadisht virechan churna an Ayurvedic formulation. The physical parameter evaluated confirms the standard of the formulated churna.
Jordan Journal of Pharmaceutical Sciences, May 8, 2020
A new, simple, specific, accurate and precise RP-HPLC method was developed for determination of S... more A new, simple, specific, accurate and precise RP-HPLC method was developed for determination of Safinamide Mesylate. In the present study, stress testing of Safinamide Mesylate was carried out according to ICH guidelines Q1A (R2). Safinamide Mesylate was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Successful separation of drug from degradation products formed under stress conditions was achieved on a Hypersil BDS C18 column (250 mm × 4.6 mm, 5.0 μ particle size) using Methanol: Phosphate Buffer pH 6.8 (80:20 % v/v), at a flow rate of 1.0 mL/min and column was maintained at 40˚C. Higher degradation was found to occur in acidic, alkaline, oxidative and photolytic condition. Lesser degradation was observed at thermal conditions. Quantification and linearity was achieved at 226 nm over the concentration range of 40-180 μg/mL for Safinamide Mesylate. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness.The developed method is suitable for the routine analysis as well as stability studies.
The purpose of the present work was to develop new, simple, specific, accurate and precise stabil... more The purpose of the present work was to develop new, simple, specific, accurate and precise stability indicating RP-HPLC method for determination of ceritinib. In the present study, stress testing of ceritinib was carried out according to ICH guidelines Q1A (R2). ceritinib was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Extensive degradation was found to occur in acidic condition. Mild degradation was observed in basic and at thermal conditions. Successful separation of drug from degradation products formed under stress conditions was achieved on a Hypersil BDS C18 column (250×4.6mm, 5.0μ particle size) using acetonitrile: acetate buffer (pH 3.7±0.05) (50:50 v/v), at a flow rate of 1.0mL/min and column was maintained at 40°C. Quantification and linearity were achieved at 272nm over the concentration range of 5-100μg/mL for ceritinib. The Correlation Coefficient was found to be 0.9960. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness. The developed method will be useful for routine analysis for samples of stability studies in the formulation and development.
Research Journal of Pharmacognosy and Phytochemistry, 2009
The current study was focused to evaluate the antipyretic potential of the hexane extract (HECC) ... more The current study was focused to evaluate the antipyretic potential of the hexane extract (HECC) and methanol extract (MECC) of the whole plant Clerodendrum colebrookianum (Family: Verbenaceae). HECC and MECC on normal body temperature and yeast -induced pyrexia in albino rats. The whole plant Clerodendrum colebrookianum was collected from Arvind Herbal lab, Rajapalayam and authenticated. The pulverized plant material (1000 gm) was extracted successively with hexane and methanol solvents in a soxhlet apparatus. Adult albino rats of either sex weighing 180 -200g were taken for the experiment. Yeast suspension (10 ml/kg body wt.) increased rectal temperature after 17 hours of subcutaneous injection. The HECC and MECC at doses of 100mg, 300mg and 500mg/kg body temperature and yeast -provoked elevated temperature in a dose dependent manner. The effect also extended up to 5 hours after the drug administration. The anti-pyretic effect of HECC and MECC was comparable to that of a standard ...
The aim of this research work was to perform pharmacological evaluation of Myricetin by using dif... more The aim of this research work was to perform pharmacological evaluation of Myricetin by using different cell lines. To check the short-term cytotoxic effect of Myricetin in HepG2 and L6 cells, a colorimetric based MTT assay was performed also the glucose utilization in both HepG2 and L6 cells was estimated in order to measure the in vitro anti-diabetic activity of Myricetin. For Lipid accumulation T3-L1 preadipocytes cells are used. For measurement of nitric oxide (NO) the RAW-264.7 cells are used. The alpha-amylase assay and alpha-glucosidase inhibition assay was performed to check if our drug is having effect in term of inhibiting α-amylase and α-glucosidase respectively. Western blot analysis was performed to check the expressions of iNOS protein in LPS treated RAW 264.7 cells before and after the exposure of Myricetin. The cytotoxicity data suggested that Myricetin displayed low level of cytotoxicity in HepG2 cells and in L6 myoblast cell lines. For glucose utilization experimen...
International Journal of Pharmaceutical Chemistry and Analysis, 2020
The nail is horny structure. Nail plate is responsible for penetration of drug across it. As it i... more The nail is horny structure. Nail plate is responsible for penetration of drug across it. As it is hard enough the penetration becomes difficult, only a fraction of topical drug penetrates across it. Hence the effective therapeutic concentration is not achieved. The nail plate may appear abnormal as a result of decreased glow. It`s involvement of nail bed, reduction of blood supply, physical or chemical features of nail bed. As a result variety of diseases occurs. 1 Oral therapies are accompanied by systemic side effects and drug interactions, while topical therapies are limited by the low permeation rate through the nail plate. These diseases can be cured by achieving desired therapeutic concentration of drug by nail drug delivery system. Human nails do not have only protective and decorative role, but can also be considered as an alternative pathway for drug delivery, especially in nail diseases such as onychomycosis or psoriasis. The physical techniques (manual and electrical nail abrasion, acid etching, ablation by lasers, microporation, application of low-frequency ultrasound and electric currents) and chemicals (thiols, sulphites, hydrogen peroxide, urea, water, enzymes) that have shown ungual enhance reactivit y. For effective topical therapy, fungal drug permeation must be enhanced. 3 This can be achieved by disrupting the nail plate using physical techniques or chemical agents. Alternatively, drug permeation into the intact nail plate may be encouraged, for examp le, by iontophoresis or by formulating the drug within a vehicle which enables high drug partition out of the vehicle and into the nail plate.
In the field of molecular modeling, docking may be a method which predicts the well-liked orienta... more In the field of molecular modeling, docking may be a method which predicts the well-liked orientation of any molecule to a receptor to make a stable complex. Knowledge of the well-liked orientation successively could also be able to predict the strength of association or binding affinity between two molecules using, for instance, scoring functions. Cyclooxygenase-2 (COX-2) inhibitors block cyclooxygenase-2 (COX-2), an enzyme that promotes inflammation. COX-2 enzyme converts to prostaglandin via arachidonic acid, causing pain and inflammatory responses. They are mainly present in places of inflammation and are responsible for formation of prostanoids (prostacyclins, prostaglandins and thromboxane) as part of the inflammatory response. COX-2 inhibitors are used to relieve pain raised from the inflammation. In the present study, the marketed COX-II inhibitors are subjected for the docking study and the drug likeness study which validate that the drugs show the optimum binding energy an...
The ICH Q3D is an important guideline to harmonize control of elemental impurities. The guideline... more The ICH Q3D is an important guideline to harmonize control of elemental impurities. The guideline sets strict limits for final drug products, limits for excipients, active pharmaceutical ingredients and other pharmaceutical drug products. The analysis of elemental imp urities in the pharmaceutical products is most important in pharmaceutical industries. In the last decade noteworthy progress has been made in the analysis of elemental impurities. The changes from using special reagents which form precipitate with the met allic impurities and are detected by colorimetric methods to using highly sophisticated instruments for analysis. This review article will cover in brief about the classes of elemental impurities, their permitted daily exposures, concentrations, risk asses sment, control strategies and instruments used for analytical testing. With the risk assessment approach, the contribution of elemental impurities of each component is assessed. The option 1 limit (based on 10 g da...
Human immunodeficiency virus (HIV) causes severe life-threatening condition, i.e., AIDS. HIV dest... more Human immunodeficiency virus (HIV) causes severe life-threatening condition, i.e., AIDS. HIV destabilises an individual’s ability to prevent infection. Therefore, the combine medication lamivudine (LVD) and tenofovir disoproxil fumarate (TDF) are prescribed to suppress the amount of HIV infection in individual’s body; thus, the individual’s immune system could function properly. Consequently, the objective of present research work was to investigate robust and sensitive liquid chromatography avenue for simultaneous determination of lamivudine and tenofovir disoproxil fumarate in pure material and combined dosage form. The reversed-phase chromatographic separation has been performed through Hypersil BDS C18 column using solvent system composed of 10 mM potassium dihydrogen phosphate (pH 4.0): acetonitrile (60:40% v/v). The determination was executed at 30 oC at 1 mL/min rate for flow of solvent system through column. The eluents of column were monitored at 265 nm using Photodiode Arr...
A simple, accurate and precise RP-HPLC method was developed for the estimation of Aceclofenac and... more A simple, accurate and precise RP-HPLC method was developed for the estimation of Aceclofenac and Rabeprazole Sodium in the bulk and marketed formulation. The method was performed by using the mobile phase containing Methnol, Water and Acetonitrile (60:30:10 v/v), pH- 6.14 was found to be most suitable for RP-HPLC as it showed sharp peak with symmetry and significant reproducible retention time for Aceclofenac (4.549 min) along with Rabeprazole Sodium (6.048 min). From the results of system suitability parameters, it was observed that the peak was sharp and symmetrical with satisfactory capacity factor and column efficiency. From the developed methods, percent content of Aceclofenac and Rabeprazole Sodium was found to be 99.97%, 99.91% and 99.94% 99.6%, 99.8% and 94.45% respectively by RP-HPLC. The method was validated by parameters like accuracy, precision, specificity, linearity, ruggedness and robustness. The results indicated that, the method is simple, accurate, precise, rugge...
تم تطوير طريقة RP-HPLC جديدة وبسيطة ومحددة ودقيقة لتحديد Safinamide Mesylate. في هذه الدراسة، تم ... more تم تطوير طريقة RP-HPLC جديدة وبسيطة ومحددة ودقيقة لتحديد Safinamide Mesylate. في هذه الدراسة، تم إجراء اختبار الإجهاد لل Safinamide Mesylate وفقا لإرشادات.ICH Q1A (R2) تعرضSafinamide Mesylate لظروف الإجهاد للتحلل المائي والأكسدة والتحلل الضوئي والتحلل المحايد. تحقق الفصل الناجح للدواء من منتجات التحلل التي تشكلت في ظروف الإجهاد على عمود Hypersil BDS C18 حجم الجسيمات 250) مم × 4.6 مم(،حجم (5.0) باستخدام الميثانول: فوسفات العازلة 6.8 80:20) ٪ ت / ت( ، في الحفاظ على معدل التدفق من 1.0 مل / دقيقة والعمود عند 40 درجة مئوية، تم العثور على تدهور أعلى تحدث في حالة الحمضية، القلوية، مؤكسد و حال للضوء وقد لوحظ تدهور أقل في الظروف الحرارية، تم تحقيق التقدير الكمي والخطي عند 226 نانومتر على مدى تركيز يتراوح بين 40 - 180 ميكروغرام / مل لسافيناميد ميسيلات، تم التحقق من صحة الطريقة للخصوصية والخطية والدقة والدقة، LOD ، LOQ والمتانة، الطريقة المطورة مناسبة للتحليل الروتيني وكذلك دراسات الاستقرار.
A new, simple, specific, accurate and precise RP-HPLC method was developed for determination of C... more A new, simple, specific, accurate and precise RP-HPLC method was developed for determination of Ceritinib. In the present study, stress testing of Ceritinib was carried out according to ICH guidelines Q1A (R2). Ceritinib was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Extensive degradation was found to occur in acidic, condition. Mild degradation was observed in basic and at thermal conditions. Successful separation of drug from degradation products formed under stress conditions was achieved on a Hypersil BDS C18 column (250 mm × 4.6 mm, 5.0 μ particle size) using acetonitrile: acetate buffer (pH 3.7 ± 0.05) (50:50 v/v), at a flow rate of 1.0 mL/min and column was maintained at 40˚C. Quantification and linearity was achieved at 272 nm over the concentration range of 5 - 100 μg/mL for Ceritinib. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness.
Lovastatinan anti-cholesteremic drug used in the treatment of hypertension. Being a BCS class II ... more Lovastatinan anti-cholesteremic drug used in the treatment of hypertension. Being a BCS class II drug, it has poor solubility and dissolution rate. Thus the aim of present study was to modify the crystals of lovastatin in the presence of additives to improve solubility, dissolution rate and other physicochemical properties. The lovastatin crystals were prepared using solvent evaporation method in the presence of additives such as PVP-K30, PEG-4000 and Poloxamer 407.The modified crystals of lovastatin were characterized by Scanning electron microscopy, FT-IR spectroscopy, Differential scanning calorimetry and X-ray diffractometry.Also the modified crystals were evaluated for solubility, dissolution rate and other physicochemical properties and compared with commercial lovastatin. The modified crystals exhibit the difference in the size and shape when compare to commercial lovastatin indicate the habit modification. The FT-IR spectra of modified crystals in the presence of additives s...
Current Trends in Pharmacy and Pharmaceutical Chemistry, 2024
The objective of this study is to evaluate the bioequivalence of generic sitagliptin tablets from... more The objective of this study is to evaluate the bioequivalence of generic sitagliptin tablets from different manufacturers using in-vitro dissolution study under biowaiver conditions through UV Spectroscopy, and compare them with the innovator brand. Materials and Methods: The dissolution media consisted of three different buffers with varying pH levels, including HCl Buffer pH 2.0, Phosphate Buffer pH 4.0, and Phosphate Buffer pH 7.2. The dissolution process was conducted using a USP type-2 dissolution apparatus with a 900 ml basket. The rotational speed of the paddle was set at 50 RPM, while maintaining a temperature of 37.5 • C +/-2 • C. Samples were collected at four different intervals as recommended by the USFDA, which were 15, 30, 45, and 60 minutes. Results: Validation parameters such as Accuracy, Precision, Linearity, LOD, and LOQ were assessed. The dissolution profiles exhibited no significant variability between different brands and within the same brand. Furthermore, the dissolution results of all tablet formulations, including the innovator brand, were analysed using the difference factor (f1) and similarity factor (f2). Conclusion: The findings from this study indicate that both generic brands of sitagliptin tablets meet the USFDA dissolution specifications and can be considered interchangeable. This is an Open Access (OA) journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
Exploration of targeted anti-tumor therapy, Aug 30, 2023
One of the major causes of death on the globe is cancer. The fourth most frequent malignancy in w... more One of the major causes of death on the globe is cancer. The fourth most frequent malignancy in women worldwide is cervical cancer. Several cancer patients are remaining incurable due to the emergence of medication resistance, despite notable advances in cancer research over the previous few decades. The importance of natural sources as possible therapeutic candidates may be significant. Anthraquinones are one of the many chemical families of natural products, and they stand out for their wide range of structural variations, notable biological activity, and low toxicity. A natural substance called emodin, an anthraquinone derivative, is present in the roots and rhizomes of several plants. This substance has demonstrated antineoplastic, antiinflammatory, antiangiogenic, and antiproliferative properties. It is also capable of preventing cancer spread and can reverse cancer cells' multidrug resistance. Emodin, a broad-spectrum inhibitor of cancer cells, have anticancer properties in many different types of biological pathways. These molecular mechanisms in cancer cells include the suppression of cell growth and proliferation, deterioration of the cell cycle arrest, the start of apoptosis, antimetastasis, and antiangiogenic impact. Therefore, the aim of the present review summarised the antiproliferative and anticarcinogenic qualities of cervical cancer of emodin.
In many areas of human life, including food, health, culture, and religion, mushrooms have had a ... more In many areas of human life, including food, health, culture, and religion, mushrooms have had a significant impact. Most people eat mushrooms for their flavor and texture. Recently, they have gained popularity as a protein source and a drug research tool. According to the phyla Ascomycota and Basidiomycota, mushrooms are fungi that produce spongy fruiting bodies, particularly those that possess a stalk and an envelope top. Mushrooms are composed of 90% water and 10% dry material. Additionally, it has a physicochemical composition that is important for nutrition. Edible mushrooms have been shown to offer therapeutic benefits, including anti-cancer, cardiovascular, hepatoprotective, neuroprotective, hypolipidemic, antiviral, antibacterial, and anti-diabetic actions. Mushrooms are a fantastic source of nourishment since they are rich in proteins, minerals, complex sugars, unsaturated fatty acids, and secondary metabolites. The composition and nutritional benefits of edible mushrooms have been carefully investigated in this review. Edible mushrooms have been used as potential therapeutic stand-ins, and bioactive components present in edible mushrooms, such as polyphenolic compounds and antioxidant activity, have also been studied. This review article may also help scientists, researchers, and medical professionals slow the advancement of some lifestyle diseases, neurological disorders, along autoimmune disorders.
International journal of pharmacy and technology, Mar 31, 2020
Microspheres are normally free flowing powders contains proteins or synthetic polymers which has ... more Microspheres are normally free flowing powders contains proteins or synthetic polymers which has biodegradable in nature and having a particle size but 200-500 μm. Number of techniques for the preparation of microspheres offers a spread of opportunities to regulate aspects of drug administration and enhance the therapeutic efficacy of a drug. A neat controlled drug delivery system can overcome a number of problems of conventional therapy and enhance therapeutic efficacy of the drug. There are various approaches in delivering therapeutic substance to the target site in sustained and controlled release fashion. These are prepared by methods like Single emulsion, Double emulsion, Polymerization, Phase separation coacervation, Emulsion solvent evaporation and solvent diffusion. Microspheres are having wide selection of applications due to controlled and sustained release.
American journal of pharmacy and health research, Oct 20, 2018
Standardization of herbal formulation is essential in order to check quality, purity, safety and ... more Standardization of herbal formulation is essential in order to check quality, purity, safety and efficacy of drug. "Swadisht Virechan" churna play an important role in constipation and detoxification due to safety and efficacy in it. Hence churna has been formulated by standard procedure and evaluated by organoleptic study, physical characteristics and physicochemical screening. One marketed formulation and one lab scale formulation were subjected to comparative standardization. The churna was standardized by determination of organoleptic characters, pH, loss on drying, ash value, extractive value, physical characteristics such as bulk density; tap density, angle of repose to determine flowability, determination of particle size, microbial content. The result of various parameters obtained from study showed that marketed formulation and lab scale formulation have comparable physical values. The flowability of formulation was found to be poor in both formulations. These studies showed that there is no uniformity in preparation of formulation which is may be due to varied geographical locations where there plants grow. The present paper reports the investigation and standardization of swadisht virechan churna an Ayurvedic formulation. The physical parameter evaluated confirms the standard of the formulated churna.
Jordan Journal of Pharmaceutical Sciences, May 8, 2020
A new, simple, specific, accurate and precise RP-HPLC method was developed for determination of S... more A new, simple, specific, accurate and precise RP-HPLC method was developed for determination of Safinamide Mesylate. In the present study, stress testing of Safinamide Mesylate was carried out according to ICH guidelines Q1A (R2). Safinamide Mesylate was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Successful separation of drug from degradation products formed under stress conditions was achieved on a Hypersil BDS C18 column (250 mm × 4.6 mm, 5.0 μ particle size) using Methanol: Phosphate Buffer pH 6.8 (80:20 % v/v), at a flow rate of 1.0 mL/min and column was maintained at 40˚C. Higher degradation was found to occur in acidic, alkaline, oxidative and photolytic condition. Lesser degradation was observed at thermal conditions. Quantification and linearity was achieved at 226 nm over the concentration range of 40-180 μg/mL for Safinamide Mesylate. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness.The developed method is suitable for the routine analysis as well as stability studies.
The purpose of the present work was to develop new, simple, specific, accurate and precise stabil... more The purpose of the present work was to develop new, simple, specific, accurate and precise stability indicating RP-HPLC method for determination of ceritinib. In the present study, stress testing of ceritinib was carried out according to ICH guidelines Q1A (R2). ceritinib was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Extensive degradation was found to occur in acidic condition. Mild degradation was observed in basic and at thermal conditions. Successful separation of drug from degradation products formed under stress conditions was achieved on a Hypersil BDS C18 column (250×4.6mm, 5.0μ particle size) using acetonitrile: acetate buffer (pH 3.7±0.05) (50:50 v/v), at a flow rate of 1.0mL/min and column was maintained at 40°C. Quantification and linearity were achieved at 272nm over the concentration range of 5-100μg/mL for ceritinib. The Correlation Coefficient was found to be 0.9960. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness. The developed method will be useful for routine analysis for samples of stability studies in the formulation and development.
Research Journal of Pharmacognosy and Phytochemistry, 2009
The current study was focused to evaluate the antipyretic potential of the hexane extract (HECC) ... more The current study was focused to evaluate the antipyretic potential of the hexane extract (HECC) and methanol extract (MECC) of the whole plant Clerodendrum colebrookianum (Family: Verbenaceae). HECC and MECC on normal body temperature and yeast -induced pyrexia in albino rats. The whole plant Clerodendrum colebrookianum was collected from Arvind Herbal lab, Rajapalayam and authenticated. The pulverized plant material (1000 gm) was extracted successively with hexane and methanol solvents in a soxhlet apparatus. Adult albino rats of either sex weighing 180 -200g were taken for the experiment. Yeast suspension (10 ml/kg body wt.) increased rectal temperature after 17 hours of subcutaneous injection. The HECC and MECC at doses of 100mg, 300mg and 500mg/kg body temperature and yeast -provoked elevated temperature in a dose dependent manner. The effect also extended up to 5 hours after the drug administration. The anti-pyretic effect of HECC and MECC was comparable to that of a standard ...
The aim of this research work was to perform pharmacological evaluation of Myricetin by using dif... more The aim of this research work was to perform pharmacological evaluation of Myricetin by using different cell lines. To check the short-term cytotoxic effect of Myricetin in HepG2 and L6 cells, a colorimetric based MTT assay was performed also the glucose utilization in both HepG2 and L6 cells was estimated in order to measure the in vitro anti-diabetic activity of Myricetin. For Lipid accumulation T3-L1 preadipocytes cells are used. For measurement of nitric oxide (NO) the RAW-264.7 cells are used. The alpha-amylase assay and alpha-glucosidase inhibition assay was performed to check if our drug is having effect in term of inhibiting α-amylase and α-glucosidase respectively. Western blot analysis was performed to check the expressions of iNOS protein in LPS treated RAW 264.7 cells before and after the exposure of Myricetin. The cytotoxicity data suggested that Myricetin displayed low level of cytotoxicity in HepG2 cells and in L6 myoblast cell lines. For glucose utilization experimen...
International Journal of Pharmaceutical Chemistry and Analysis, 2020
The nail is horny structure. Nail plate is responsible for penetration of drug across it. As it i... more The nail is horny structure. Nail plate is responsible for penetration of drug across it. As it is hard enough the penetration becomes difficult, only a fraction of topical drug penetrates across it. Hence the effective therapeutic concentration is not achieved. The nail plate may appear abnormal as a result of decreased glow. It`s involvement of nail bed, reduction of blood supply, physical or chemical features of nail bed. As a result variety of diseases occurs. 1 Oral therapies are accompanied by systemic side effects and drug interactions, while topical therapies are limited by the low permeation rate through the nail plate. These diseases can be cured by achieving desired therapeutic concentration of drug by nail drug delivery system. Human nails do not have only protective and decorative role, but can also be considered as an alternative pathway for drug delivery, especially in nail diseases such as onychomycosis or psoriasis. The physical techniques (manual and electrical nail abrasion, acid etching, ablation by lasers, microporation, application of low-frequency ultrasound and electric currents) and chemicals (thiols, sulphites, hydrogen peroxide, urea, water, enzymes) that have shown ungual enhance reactivit y. For effective topical therapy, fungal drug permeation must be enhanced. 3 This can be achieved by disrupting the nail plate using physical techniques or chemical agents. Alternatively, drug permeation into the intact nail plate may be encouraged, for examp le, by iontophoresis or by formulating the drug within a vehicle which enables high drug partition out of the vehicle and into the nail plate.
In the field of molecular modeling, docking may be a method which predicts the well-liked orienta... more In the field of molecular modeling, docking may be a method which predicts the well-liked orientation of any molecule to a receptor to make a stable complex. Knowledge of the well-liked orientation successively could also be able to predict the strength of association or binding affinity between two molecules using, for instance, scoring functions. Cyclooxygenase-2 (COX-2) inhibitors block cyclooxygenase-2 (COX-2), an enzyme that promotes inflammation. COX-2 enzyme converts to prostaglandin via arachidonic acid, causing pain and inflammatory responses. They are mainly present in places of inflammation and are responsible for formation of prostanoids (prostacyclins, prostaglandins and thromboxane) as part of the inflammatory response. COX-2 inhibitors are used to relieve pain raised from the inflammation. In the present study, the marketed COX-II inhibitors are subjected for the docking study and the drug likeness study which validate that the drugs show the optimum binding energy an...
The ICH Q3D is an important guideline to harmonize control of elemental impurities. The guideline... more The ICH Q3D is an important guideline to harmonize control of elemental impurities. The guideline sets strict limits for final drug products, limits for excipients, active pharmaceutical ingredients and other pharmaceutical drug products. The analysis of elemental imp urities in the pharmaceutical products is most important in pharmaceutical industries. In the last decade noteworthy progress has been made in the analysis of elemental impurities. The changes from using special reagents which form precipitate with the met allic impurities and are detected by colorimetric methods to using highly sophisticated instruments for analysis. This review article will cover in brief about the classes of elemental impurities, their permitted daily exposures, concentrations, risk asses sment, control strategies and instruments used for analytical testing. With the risk assessment approach, the contribution of elemental impurities of each component is assessed. The option 1 limit (based on 10 g da...
Human immunodeficiency virus (HIV) causes severe life-threatening condition, i.e., AIDS. HIV dest... more Human immunodeficiency virus (HIV) causes severe life-threatening condition, i.e., AIDS. HIV destabilises an individual’s ability to prevent infection. Therefore, the combine medication lamivudine (LVD) and tenofovir disoproxil fumarate (TDF) are prescribed to suppress the amount of HIV infection in individual’s body; thus, the individual’s immune system could function properly. Consequently, the objective of present research work was to investigate robust and sensitive liquid chromatography avenue for simultaneous determination of lamivudine and tenofovir disoproxil fumarate in pure material and combined dosage form. The reversed-phase chromatographic separation has been performed through Hypersil BDS C18 column using solvent system composed of 10 mM potassium dihydrogen phosphate (pH 4.0): acetonitrile (60:40% v/v). The determination was executed at 30 oC at 1 mL/min rate for flow of solvent system through column. The eluents of column were monitored at 265 nm using Photodiode Arr...
A simple, accurate and precise RP-HPLC method was developed for the estimation of Aceclofenac and... more A simple, accurate and precise RP-HPLC method was developed for the estimation of Aceclofenac and Rabeprazole Sodium in the bulk and marketed formulation. The method was performed by using the mobile phase containing Methnol, Water and Acetonitrile (60:30:10 v/v), pH- 6.14 was found to be most suitable for RP-HPLC as it showed sharp peak with symmetry and significant reproducible retention time for Aceclofenac (4.549 min) along with Rabeprazole Sodium (6.048 min). From the results of system suitability parameters, it was observed that the peak was sharp and symmetrical with satisfactory capacity factor and column efficiency. From the developed methods, percent content of Aceclofenac and Rabeprazole Sodium was found to be 99.97%, 99.91% and 99.94% 99.6%, 99.8% and 94.45% respectively by RP-HPLC. The method was validated by parameters like accuracy, precision, specificity, linearity, ruggedness and robustness. The results indicated that, the method is simple, accurate, precise, rugge...
تم تطوير طريقة RP-HPLC جديدة وبسيطة ومحددة ودقيقة لتحديد Safinamide Mesylate. في هذه الدراسة، تم ... more تم تطوير طريقة RP-HPLC جديدة وبسيطة ومحددة ودقيقة لتحديد Safinamide Mesylate. في هذه الدراسة، تم إجراء اختبار الإجهاد لل Safinamide Mesylate وفقا لإرشادات.ICH Q1A (R2) تعرضSafinamide Mesylate لظروف الإجهاد للتحلل المائي والأكسدة والتحلل الضوئي والتحلل المحايد. تحقق الفصل الناجح للدواء من منتجات التحلل التي تشكلت في ظروف الإجهاد على عمود Hypersil BDS C18 حجم الجسيمات 250) مم × 4.6 مم(،حجم (5.0) باستخدام الميثانول: فوسفات العازلة 6.8 80:20) ٪ ت / ت( ، في الحفاظ على معدل التدفق من 1.0 مل / دقيقة والعمود عند 40 درجة مئوية، تم العثور على تدهور أعلى تحدث في حالة الحمضية، القلوية، مؤكسد و حال للضوء وقد لوحظ تدهور أقل في الظروف الحرارية، تم تحقيق التقدير الكمي والخطي عند 226 نانومتر على مدى تركيز يتراوح بين 40 - 180 ميكروغرام / مل لسافيناميد ميسيلات، تم التحقق من صحة الطريقة للخصوصية والخطية والدقة والدقة، LOD ، LOQ والمتانة، الطريقة المطورة مناسبة للتحليل الروتيني وكذلك دراسات الاستقرار.
A new, simple, specific, accurate and precise RP-HPLC method was developed for determination of C... more A new, simple, specific, accurate and precise RP-HPLC method was developed for determination of Ceritinib. In the present study, stress testing of Ceritinib was carried out according to ICH guidelines Q1A (R2). Ceritinib was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Extensive degradation was found to occur in acidic, condition. Mild degradation was observed in basic and at thermal conditions. Successful separation of drug from degradation products formed under stress conditions was achieved on a Hypersil BDS C18 column (250 mm × 4.6 mm, 5.0 μ particle size) using acetonitrile: acetate buffer (pH 3.7 ± 0.05) (50:50 v/v), at a flow rate of 1.0 mL/min and column was maintained at 40˚C. Quantification and linearity was achieved at 272 nm over the concentration range of 5 - 100 μg/mL for Ceritinib. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness.
Lovastatinan anti-cholesteremic drug used in the treatment of hypertension. Being a BCS class II ... more Lovastatinan anti-cholesteremic drug used in the treatment of hypertension. Being a BCS class II drug, it has poor solubility and dissolution rate. Thus the aim of present study was to modify the crystals of lovastatin in the presence of additives to improve solubility, dissolution rate and other physicochemical properties. The lovastatin crystals were prepared using solvent evaporation method in the presence of additives such as PVP-K30, PEG-4000 and Poloxamer 407.The modified crystals of lovastatin were characterized by Scanning electron microscopy, FT-IR spectroscopy, Differential scanning calorimetry and X-ray diffractometry.Also the modified crystals were evaluated for solubility, dissolution rate and other physicochemical properties and compared with commercial lovastatin. The modified crystals exhibit the difference in the size and shape when compare to commercial lovastatin indicate the habit modification. The FT-IR spectra of modified crystals in the presence of additives s...
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