STABILITY INDICATION RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF BEXAGLIFLOZIN IN MARKETED FORMULATION

This study focuses on the development and validation of a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the accurate estimation of Bexagliflozin in a marketed formulation. Bexagliflozin, a novel sodium-glucose cotransporter-2 (SGLT-2) inhibitor, is widely used for the management of type 2 diabetes mellitus. The proposed RP-HPLC method demonstrates stability indicating attributes, enabling the assessment of drug integrity in the presence of potential degradants. The validation parameters, including specificity, linearity, precision, accuracy, robustness, and system suitability, were systematically evaluated. Additionally, the method was successfully applied to quantify Bexagliflozin in a commercially available formulation, providing a reliable tool for routine quality control analysis. The developed method offers a valuable contribution to the pharmaceutical analytical toolbox, ensuring the accurate determination of Bexagliflozin in the presence of potential degradation products.