Novel Simplified Analytical Method for Stress Degradation Study of Empagliflozin an Oral
Anti-diabetic Agent by RP-HPLC Method
Arulselvan Murugesan1* and Annapurna Mukthinuthalapati Mathrusri2
1Department of Pharmaceutical Analysis, AIKTC School of Pharmacy, New Panvel Dist-Raigad (M.S.), India
2Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India
*Corresponding Author: Arulselvan Murugesan, Department of Pharmaceutical Analysis, AIKTC School of Pharmacy, New Panvel Dist-Raigad (M.S.), India.
September 21, 2021; Published: December 09, 2021
The present study involved developing novel, simplified analytical methods for estimating Empagliflozin in API and finished formulation as per the guidelines of ICH. Meanwhile the study focused on conducting forced degradation studies for Empagliflozin to identify the degraded products and its percentage. The applied chromatographic separation method as follows RP-HPLC ZORBAxC18 (250 x 4.6mm, 5μm particle size) with a mobile phase consisting of Acetate buffer: Acetonitrile in a ratio of 60:40% v/v at a flow rate of 1.0 mL/min with an injection volume of 10μl with 6 minutes run time. The Retention time of Empagliflozin was found to be 2.57 ± 0.05min and detected at 232 nm UV wavelength. The method was found to be linear based on the Linear regression equation y = 61309 x- 8123 with correlation coefficient 0.9999. Validation parameters performed as per the prescribed protocol. Stress degradation experiments were performed by exposing the Empagliflozin into acidic, alkaline, oxidative, thermal, and photolytic conditions, withdrawing samples at different time intervals and injected into the system as per ICH guidelines to analyze the drug. The developed method was novel, precise, simple, and accurate with low consumption of organic solvents to estimate Empagliflozin in API and bulk formulation compared to previously reported studies.
Keywords: Empagliflozin; Stress degradation; Validation; ICH; Forced stability; SGLT2; RP-HPL
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