Comprehensive Forced Degradation and Degradation Kinetics of Empagliflozin Using RP-HPLC and In-Silico Toxicity and ADMET Profiling of Degradants
Abstract
Empagliflozin is a selective Sodium–Glucose Co-Transporter-2 (SGLT2) inhibitor widely used for the treatment of Type 2 Diabetes Mellitus. The stability of pharmaceutical compounds is an important quality attribute as degradation may affect drug efficacy, safety, and shelf life. Therefore, the present study aims to develop and validate a stability-indicating Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for the analysis of Empagliflozin and to investigate its degradation behavior under various stress conditions. Forced degradation studies will be carried out according to International Council for Harmonisation (ICH) guidelines under acidic, alkaline, oxidative, thermal, photolytic, and neutral hydrolytic conditions to evaluate the intrinsic stability of the drug. The developed RPHPLC method will be optimized and validated with respect to specificity, linearity, accuracy, precision, robustness, and system suitability. The degradation products formed during stress studies will be separated and analyzed to establish the stability-indicating nature of the method. Furthermore, degradation kinetics will be studied to determine the degradation rate constant and half-life of Empagliflozin under different stress conditions. In addition, in-silico toxicity and ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) profiling of the generated degradants will be performed using computational tools such as SwissADME, pkCSM, and ProTox-II. The study is…
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