Abstract

VALIDATED STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF PROCESS RELATED IMPURITIES IN EMPAGLIFLOZIN DRUG SUBSTANCES

Sushil H. Jaiswal*, Dr. M. V. Katariya, Dr. V. R. Katariya, Dr. G. S. Karva, Kishor Koshe

Abstract

Four process related impurities in Empagliflozin drug substance was detected and quantified using reverse phase high performance liquid chromatographic method. The chromatographic separation was achieved on Inertsil C8 (250mm×4.6 mm, 5μm) column under gradient elucidation using 0.1% orthophosphoric acid and acetonitrile as mobile phase with UV detection at 230nm and a flow rate of 1.2 ml/min. The column temperature was maintained at 55°C throughout the analysis. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic, thermal and humidity conditions. The developed method was validated with respect to sensitivity, linearity, precision, accuracy and robustness. It can be implemented for routine quality control analysis and stability testing of Empagliflozin.

Keywords: Empagliflozin, HPLC, Degradation, Process impurity, Validation, ICH guidelines.