Development and Validation by Ashwini

“DEVELOPMENT AND VALIDATION OF
SIMPLE ANALYTICAL METHODS FOR THE

ESTIMATION OF MOXIFLOXACIN IN BULK
AND PHARMACEUTICAL DOSAGE FORM”
UNDER THE GUIDANCE OF: PRESENTED BY:

Dr.Ravindranath. G.Ashwini
HOD,Pharmaceutical Analysis.
www.pharmacygraduates.org
Regd no.100809885003
1
TABLE OF CONTENTS
S.NO CONTENTS PAGE NO
Introduction 3-4
Drug profile 5-6
Objectives 7
Instrumentation 8-10
Methodology 11
conclusion
Reference 1
www.pharmacygraduates.org 2
Pharmaceutical analysis comprises the procedures necessary to
determine the identity, strength, quality and purity of substances
of therapeutic importance.
 Quality is important in every product or service, but it is vital in
medicines as it involves life.
 Analytical techniques that are generally used for drug analysis are
o Chromatographic methods,
o Spectral methods,
o Biological and Microbiological methods.
 Validation of Analytical Method
validation is the process used to confirm that the analytical
procedure employed for a specific test is suitable
for its intended use.
The various validation parameters are:
 Accuracy,
 Precision (Repeatability and Reproducibility),
 Linearity and Range,
 Limit of detection (LOD) / Limit of quantitation (LOQ),
 Selectivity / Specificity,
 Robustness / Ruggedness,
 Stability and System suitability studies
 Moxifloxacin is a fourth-generation synthetic fluoroquinolone
antibacterial agent
 Nomenclature:1-cyclopropyl-7-[(1s,6s)-2,8-diaz[4.3.0]non-8-yl]-6-fluoro-
8-methoxy-4-oxo-quinoline carboxylic acid
 Molecular formula : C21H24F N3O4.HCL. .
 Molecular weight : 401.431 g/mol .
 Appearance : It occurs as a Yellow to yellow crystalline substance
 Solubility : It is soluble in methanol, sparingly soluble in water and
practically insoluble in acetone.
 Category : Antibacterial agent.
The Objective of this dissertation work is as follows
 Aim of the present work is to Develop some new analytical methods for the
estimation of moxifloxacin in bulk and drug formulations
 To Develop rapid, sensitive and selective method
 Economic and accurate method
 Method validation according to ICH guidelines.
INSTRUMENTATION
 HPLC is one mode of chromatography,
 Chromatographic processes can be defined as separation techniques
involving mass-transfer between stationary and mobile phases.
 HPLC utilizes a liquid mobile phase to separate the components of a
mixture.
 These components (or analytes) are first dissolved in a solvent, and then
forced to flow through a chromatographic column under high pressure. In
the column, the mixture is resolved into its components.
 As a result, HPLC acquires a high degree of versatility not found in other
chromatographic systems and has the ability to easily separate a wide
variety of chemical mixtures.

BLOCK DIAGRAM OF HPLC:
 Selection of analytical wavelength
 Preparation of stock solutions
 Calibration curve for the Moxifloxacin
 Sample preparation for determination of Moxifloxacin from dosage
form
 Validation of Spectrophotometric methods
 Gather / generate background information – obtain Physico-chemical
properties,
 Determine, if special handling / treatment of sample is needed,
 From physic-chemical properties select detector,
 Select LC mode and perform initial runs,
 Optimize separation conditions; peak Rs , equation parameters,
 Summarize methodology finalize documentation,
 Validate method / Transfer to control Laboratory.
High Performance Liquid Chromatography
Instrument ( Agilent technologies 1200 series
with Eglite software)
Injector
Column
Wavelength
Flow rate
Injection volume
Mobile phase
Temperature
Run time
Reference
 Validated spectrophotometric methods for the estimation of moxifloxacin in
bulk and pharmaceutical formulations.
Motwani SK, Chopra s, Ahmad FJ, Khar RK.
Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard,
Hamdard Nagar, New Delhi 110062, India. [email protected]
Validated spectrophotometric methods for the estimation of moxifloxacin in
bulk and pharmaceutical formulations
References and further reading may be available for this article.
Sanjay K. Motwani , Shruti Chopra Farhan J. Ahmad1 and Roop K. Khar1, a
a
Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard,
Hamdard Nagar, New Delhi 110062, India
 Optimization and validation of the direct HPLC method for the
determination of moxifloxacin in plasma Aleksandra Laban-Djurdjevića,
Milena Jelikić-Stankovb and Predrag Djurdjević
aMedicines and Medical Devices Agency of Serbia, V. Stepe 458, 11152
Belgrade, Serbia and MontenegrobFaculty of Pharmacy, V. Stepe 450,
11152 Belgrade, Serbia and MontenegrocFaculty of Science, P.O. Box 60,
34000 Kragujevac, Serbia and Montenegro
 Web sites:
www.pubmed.com
www.sciencedirect.com
www.google.com
www.pharmacygraduates.org

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“DEVELOPMENT AND VALIDATION OF

SIMPLE ANALYTICAL METHODS FOR THE

UNDER THE GUIDANCE OF: PRESENTED BY:

 To Develop rapid, sensitive and selective method

 Economic and accurate method

 Method validation according to ICH guidelines.

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