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Ph.D.
(Pharmacy)
DEVELOPMENT AND VALIDATION OF CHROMATOGRAPHIC ANALYSIS
OF RELATED SUBSTANCES OF NOVEL ANTI DIABETIC DRUGS

Ph.D. Scholar : Patel Nileshkumar Mangalbhai
Research Supervisor : Dr. Sejal K Patel

Regi. No.: 16146021014
Abstract :
The Present work comprises nine major chapters, which begin with an introductory part
and literature survey is followed by Method development and Method validation of
Reverse Phase HPLC chromatographic method.
Research work includes RP-HPLC technique for estimation and detection of different
impurities present in Active Pharmaceutical Ingredients or may be generated during the
formulation preparation or during storage of formulation. Research work includes
different trials taken on different mobile phases and different stationary phases to
separate different impurities. Methods are also specific and selective for detection and
quantifying impurities at LOQ to 150% of specification level.

Impurities or Related substances in pharmaceuticals are unwanted chemicals that
remain with the active pharmaceutical ingredients (APIs), or develop during stability
testing, or developing during formulation or upon aging of both API and formulation. A
simple and very sensitive methods developed for the estimation of impurities present in
anti diabetic drugs formulations by Reverse Phase High-Performance Liquid
Chromatographic method.

Methods are capable to detect impurities at very low levels (1µg/mL). Above mentioned
all methods were validated for the parameters like linearity and range, precision, accuracy,
limit of detection and quantification, robustness, specificity, solution stability, force
degradation study according to the ICH Q2R1 guideline.
Key words: Empaglifozin, Dapaglifozin, Canaglifozin, Stress study, RP-HPLC , Stability
indicating method, Force degradation, Method Development, Method Validation, ICH Q2-
R1, Mass balance, SGLT-2 inhibitors, Anti-diabetic drug

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