Simple, fast and reliable spectrophotometric methods were developed for determination of Ondanset... more Simple, fast and reliable spectrophotometric methods were developed for determination of Ondansetron Hydrochloride in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Distilled Water. The quantitative determination of the drug was carried out using the second order Derivative Area under Curve method values measured at 248-254nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Ondansetron Hydrochloride using 2-10μg/ml (r=0.9986) for second order Derivative Area under Curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of Ondansetron Hydrochloride in pharmaceutical formulations.
Controlled drug delivery systems (DDS) have several advantages
compared to the traditional dosage... more Controlled drug delivery systems (DDS) have several advantages compared to the traditional dosage forms. From the last few decades, there has been a considerable research on the basis of Novel drug delivery system, using particulate drug delivery systems as such drug carriers for small and large molecules. Nanoparticles, Liposomes, Microspheres, Niosomes, Pronisomes, Ethosomes, and Pro-liposomes have been used as drug carrier in vesicle drug delivery system. Various polymers have been used in the formation of Nanocarriers. Nanocarriers are colloidal particulate systems with size ranging between 10-1000 nm. This are used for the diagnosis, treatment and monitoring of various diseases and physical approach to alter and improve the pharmacokinetic and pharmacodynamics properties of various types of drug molecules. Controlled and targeted delivery is one of the most valuable requirements from a carrier, which involves multidisciplinary site specific or targeted approach. Nanoparticulate drug delivery system may offer plenty of advantages over conventional dosage forms, which includes improved efficacy, reduced toxicity, enhanced biodistribution and improved patient compliance.
This article covers fundamental basics of quality complaint. Complaints show customer dissatisfac... more This article covers fundamental basics of quality complaint. Complaints show customer dissatisfaction about the quality of a pharmaceutical Product. Complaints may be about: Services, delivery, quality of product, communication, response time, documentation, billing, follow up etc. a good complaint handling system gives the company an opportunity to improve the quality of their products, being a good tool for the maintenance of Good Manufacturing Practices. A systematic procedure must be developed and implemented in order to register and investigate each complaint received and not only the Quality Assurance area must be involved. Systematic handling of complaints maintains a good relationship between customer and company. Thus the aim of this article is to discuss the main steps of a good complaint handling procedure that can be readily implemented in pharmaceutical companies.
The aim of the present study is to develop and evaluate the immediate release tablet of Imipramin... more The aim of the present study is to develop and evaluate the immediate release tablet of Imipramine hydrochloride by direct compression method. The superdisintegrant crospovidone (CP), croscarmellose sodium (CCS) and sodium starch glycolate (SSG) were used for immediate release of drug from tablet. The prepared tablets were evaluated for all pre-compression parameters and post-compression parameters. The drug-excipients interaction was investigated by FTIR. All formulation showed compliances with Pharmacopoeial standards. The study reveals that formulations prepared by direct compression F3 exhibits highest dissolution using crospovidone showed faster drug release 99.65 % over the period of 12 min while disintegration time of the tablet was showed 28 sec comparison to other formulations of Imipramine hydrochloride.
A simple, accurate, rapid and precise isocratic reversed-phase high-performance liquid chromatogr... more A simple, accurate, rapid and precise isocratic reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous determination of clopidogrel bisulphate in tablet. The chromatographic separation was carried out on an Inertial BDS C18 250 x 4.6 x 5 mm column with a mixture of Methanol: Water (70:30) as mobile phase; at a flow rate of 1 ml/min. UV detection was performed at 222 nm. The retention times of clopidogrel bisulphate are 3.45. Calibration plots were linear (r 2>0.994) over the concentration range 2-10 μg/ml for clopidogrel bisulphate. The method was validated for accuracy, precision, linearity, and LOD & LOQ. The proposed method was successfully used for quantitative analysis of tablet. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of clopidogrel bisulphate in bulk drug and tablet dosage form.
Simple, fast and reliable spectrophotometric methods were developed for determination of Omeprazo... more Simple, fast and reliable spectrophotometric methods were developed for determination of Omeprazole in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Methanol. The quantitative determination of the drug was carried out using the zero order derivative values measured at 303 nm and the area under the curve method values measured at 300-305 nm (n=2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Omeprazole using 2-10μg/.ml (r²=0.9985 and r²=0.9959) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of Omeprazole in tablets.
Simple, fast and reliable spectrophotometric methods were developed for determination of Ondanset... more Simple, fast and reliable spectrophotometric methods were developed for determination of Ondansetron Hydrochloride in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Distilled Water. The quantitative determination of the drug was carried out using the second order Derivative Area under Curve method values measured at 248-254nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Ondansetron Hydrochloride using 2-10μg/ml (r=0.9986) for second order Derivative Area under Curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of Ondansetron Hydrochloride in pharmaceutical formulations.
Controlled drug delivery systems (DDS) have several advantages
compared to the traditional dosage... more Controlled drug delivery systems (DDS) have several advantages compared to the traditional dosage forms. From the last few decades, there has been a considerable research on the basis of Novel drug delivery system, using particulate drug delivery systems as such drug carriers for small and large molecules. Nanoparticles, Liposomes, Microspheres, Niosomes, Pronisomes, Ethosomes, and Pro-liposomes have been used as drug carrier in vesicle drug delivery system. Various polymers have been used in the formation of Nanocarriers. Nanocarriers are colloidal particulate systems with size ranging between 10-1000 nm. This are used for the diagnosis, treatment and monitoring of various diseases and physical approach to alter and improve the pharmacokinetic and pharmacodynamics properties of various types of drug molecules. Controlled and targeted delivery is one of the most valuable requirements from a carrier, which involves multidisciplinary site specific or targeted approach. Nanoparticulate drug delivery system may offer plenty of advantages over conventional dosage forms, which includes improved efficacy, reduced toxicity, enhanced biodistribution and improved patient compliance.
This article covers fundamental basics of quality complaint. Complaints show customer dissatisfac... more This article covers fundamental basics of quality complaint. Complaints show customer dissatisfaction about the quality of a pharmaceutical Product. Complaints may be about: Services, delivery, quality of product, communication, response time, documentation, billing, follow up etc. a good complaint handling system gives the company an opportunity to improve the quality of their products, being a good tool for the maintenance of Good Manufacturing Practices. A systematic procedure must be developed and implemented in order to register and investigate each complaint received and not only the Quality Assurance area must be involved. Systematic handling of complaints maintains a good relationship between customer and company. Thus the aim of this article is to discuss the main steps of a good complaint handling procedure that can be readily implemented in pharmaceutical companies.
The aim of the present study is to develop and evaluate the immediate release tablet of Imipramin... more The aim of the present study is to develop and evaluate the immediate release tablet of Imipramine hydrochloride by direct compression method. The superdisintegrant crospovidone (CP), croscarmellose sodium (CCS) and sodium starch glycolate (SSG) were used for immediate release of drug from tablet. The prepared tablets were evaluated for all pre-compression parameters and post-compression parameters. The drug-excipients interaction was investigated by FTIR. All formulation showed compliances with Pharmacopoeial standards. The study reveals that formulations prepared by direct compression F3 exhibits highest dissolution using crospovidone showed faster drug release 99.65 % over the period of 12 min while disintegration time of the tablet was showed 28 sec comparison to other formulations of Imipramine hydrochloride.
A simple, accurate, rapid and precise isocratic reversed-phase high-performance liquid chromatogr... more A simple, accurate, rapid and precise isocratic reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous determination of clopidogrel bisulphate in tablet. The chromatographic separation was carried out on an Inertial BDS C18 250 x 4.6 x 5 mm column with a mixture of Methanol: Water (70:30) as mobile phase; at a flow rate of 1 ml/min. UV detection was performed at 222 nm. The retention times of clopidogrel bisulphate are 3.45. Calibration plots were linear (r 2>0.994) over the concentration range 2-10 μg/ml for clopidogrel bisulphate. The method was validated for accuracy, precision, linearity, and LOD & LOQ. The proposed method was successfully used for quantitative analysis of tablet. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of clopidogrel bisulphate in bulk drug and tablet dosage form.
Simple, fast and reliable spectrophotometric methods were developed for determination of Omeprazo... more Simple, fast and reliable spectrophotometric methods were developed for determination of Omeprazole in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Methanol. The quantitative determination of the drug was carried out using the zero order derivative values measured at 303 nm and the area under the curve method values measured at 300-305 nm (n=2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Omeprazole using 2-10μg/.ml (r²=0.9985 and r²=0.9959) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of Omeprazole in tablets.
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Papers by Santosh Jadhav
compared to the traditional dosage forms. From the last few decades,
there has been a considerable research on the basis of Novel drug
delivery system, using particulate drug delivery systems as such drug
carriers for small and large molecules. Nanoparticles, Liposomes,
Microspheres, Niosomes, Pronisomes, Ethosomes, and Pro-liposomes
have been used as drug carrier in vesicle drug delivery system. Various
polymers have been used in the formation of Nanocarriers.
Nanocarriers are colloidal particulate systems with size ranging
between 10-1000 nm. This are used for the diagnosis, treatment and
monitoring of various diseases and physical approach to alter and
improve the pharmacokinetic and pharmacodynamics properties of
various types of drug molecules. Controlled and targeted delivery is one
of the most valuable requirements from a carrier, which involves multidisciplinary
site specific or targeted approach. Nanoparticulate drug
delivery system may offer plenty of advantages over conventional
dosage forms, which includes improved efficacy, reduced toxicity,
enhanced biodistribution and improved patient compliance.
about the quality of a pharmaceutical Product. Complaints may be about: Services, delivery, quality of
product, communication, response time, documentation, billing, follow up etc. a good complaint
handling system gives the company an opportunity to improve the quality of their products, being a
good tool for the maintenance of Good Manufacturing Practices. A systematic procedure must be
developed and implemented in order to register and investigate each complaint received and not only
the Quality Assurance area must be involved. Systematic handling of complaints maintains a good
relationship between customer and company. Thus the aim of this article is to discuss the main steps of
a good complaint handling procedure that can be readily implemented in pharmaceutical companies.
been developed and validated for simultaneous determination of clopidogrel bisulphate in tablet. The chromatographic
separation was carried out on an Inertial BDS C18 250 x 4.6 x 5 mm column with a mixture of Methanol: Water (70:30) as
mobile phase; at a flow rate of 1 ml/min. UV detection was performed at 222 nm. The retention times of clopidogrel bisulphate
are 3.45. Calibration plots were linear (r 2>0.994) over the concentration range 2-10 μg/ml for clopidogrel bisulphate. The
method was validated for accuracy, precision, linearity, and LOD & LOQ. The proposed method was successfully used for
quantitative analysis of tablet. No interference from any component of pharmaceutical dosage form was observed. Validation
studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation
confirm the suitability of the method for routine determination of clopidogrel bisulphate in bulk drug and tablet dosage form.
compared to the traditional dosage forms. From the last few decades,
there has been a considerable research on the basis of Novel drug
delivery system, using particulate drug delivery systems as such drug
carriers for small and large molecules. Nanoparticles, Liposomes,
Microspheres, Niosomes, Pronisomes, Ethosomes, and Pro-liposomes
have been used as drug carrier in vesicle drug delivery system. Various
polymers have been used in the formation of Nanocarriers.
Nanocarriers are colloidal particulate systems with size ranging
between 10-1000 nm. This are used for the diagnosis, treatment and
monitoring of various diseases and physical approach to alter and
improve the pharmacokinetic and pharmacodynamics properties of
various types of drug molecules. Controlled and targeted delivery is one
of the most valuable requirements from a carrier, which involves multidisciplinary
site specific or targeted approach. Nanoparticulate drug
delivery system may offer plenty of advantages over conventional
dosage forms, which includes improved efficacy, reduced toxicity,
enhanced biodistribution and improved patient compliance.
about the quality of a pharmaceutical Product. Complaints may be about: Services, delivery, quality of
product, communication, response time, documentation, billing, follow up etc. a good complaint
handling system gives the company an opportunity to improve the quality of their products, being a
good tool for the maintenance of Good Manufacturing Practices. A systematic procedure must be
developed and implemented in order to register and investigate each complaint received and not only
the Quality Assurance area must be involved. Systematic handling of complaints maintains a good
relationship between customer and company. Thus the aim of this article is to discuss the main steps of
a good complaint handling procedure that can be readily implemented in pharmaceutical companies.
been developed and validated for simultaneous determination of clopidogrel bisulphate in tablet. The chromatographic
separation was carried out on an Inertial BDS C18 250 x 4.6 x 5 mm column with a mixture of Methanol: Water (70:30) as
mobile phase; at a flow rate of 1 ml/min. UV detection was performed at 222 nm. The retention times of clopidogrel bisulphate
are 3.45. Calibration plots were linear (r 2>0.994) over the concentration range 2-10 μg/ml for clopidogrel bisulphate. The
method was validated for accuracy, precision, linearity, and LOD & LOQ. The proposed method was successfully used for
quantitative analysis of tablet. No interference from any component of pharmaceutical dosage form was observed. Validation
studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation
confirm the suitability of the method for routine determination of clopidogrel bisulphate in bulk drug and tablet dosage form.