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Ph.D.
(Pharmacy)
DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR
ESTIMATION OF SOME NEW ANTI-DIABETIC DRUGS IN BULK AND
THEIR COMBINATION USING QbD APPROACHES
Ph.D. Scholar : Dave Vidhi Sureshkumar
Research Supervisor : Dr. Paresh U. Patel

Regi. No.: 16146021003
Abstract :
The present work represents the Method Developement and Validation of Analytical
Methods for some newer Anti Diabetic drugs Dapagliflozin, Canagliflozin, Remogliflozin
and Metformin HCl. The aim of the present work was to develop a simple, rapid, sensitive,
accurate, precise, and cost-effectivemethod for estimation of Canagliflozin, Dapagliflozin,
Remogliflozin and Metformin HClin bulk and formulations by UV, RP HPLC and Stability
Indicating method by applying Quality By Design Approach, so that it can be applied for
the routine analysis of drug in Quality Control laboratories andestimation of degradation
behavior of drug by RP-HPLC.

For UV Analytical Methods Shimadzu 1800 UV Spectrophotometer was used where
Methanol was taken as a Solvent. For HPLC Method Development Agilent make of HPLC
was used using Phosphate Buffer, Acetonitrile, and Methanol in different Proportions as
per the drug under Study.

For application of QBD Approach, Design Expert®13 software was used.

After Method Development as per ICH guidelines, Validation has been performed. In
Linearity correlation coefficient was found to be less than 0.996. For Precision % RSD
were found to be less than 1.5, which indicates that all developed methods are precise.
For Accuracy % Recovery was found to be 98 % - 102%, which indicates all methods are
Accurate.
For HPLC, various system suitability parameters were found to be specific as per ICH
guideline i.e tailing, theoretical plates, Resolution. QBD Approach was used during Method
Development by HPLC, which helps to make all the methods Sensitive and Cost-effective.
After all the methods development, Statistical Analysis was performed.

Key words: Analytical Method, Validation, ICH, QbD

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