Abstract

REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF EMPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Swathi K.*, Kavya V., Vikas S. M., Soujanya, Arun Gowda M. P.

ABSTRACT

Empagliflozin is a highly selective sodium-glucose cotransporter-2 (SGLT2) inhibitor extensively used in the treatment of type 2 diabetes mellitus and is also indicated for reducing the risk of cardiovascular and renal complications. This review provides a comprehensive overview of the analytical methods reported for the qualitative and quantitative estimation of Empagliflozin, including UV-visible spectrophotometry, reverse-phase high-performance liquid chromatography (RP-HPLC), high-performance thin-layer chromatography (HPTLC), ultra-performance liquid chromatography (UPLC), high-performance liquid chromatography coupled with mass spectrometry (LC-MS/MS), and stability-indicating methods. The review discusses method development approaches, optimization of analytical conditions and validation parameters according to the International Council for Harmonization guidelines including specificity, linearity, accuracy, precision, robustness, detection limit, quantification limit, and system suitability. In addition comparative evaluation of the reported analytical methods, degradation behavior and their applications in routine quality control, dissolution testing, stability studies and pharmaceutical research are presented. This review serves as a valuable reference for researchers, academicians, and pharmaceutical analysts involved in the development and validation of analytical methods for Empagliflozin and highlights future opportunities for the development of rapid, eco-friendly, and cost-effective analytical techniques.

Keywords: UV-visible spectrophotometry, RP-HPLC, HPTLC, UPLC, LC-MS/MS, ICH guidelines.