Development and Validation of HPTLC Method for Simultaneous Quantification of Dapagliflozin and Vildagliptin in Tablet Dosage Form

Abstract

In recent times, the combination of Dapagliflozin and Vildagliptin has emerged as a therapeutic option for managing diabetes. This study presents the development of a rapid, selective, sensitive, and robust high-performance thin-layer chromatography (HPTLC) method for the simultaneous quantification of Dapagliflozin (DAPA) and Vildagliptin (VILG) in both their pure forms and in a commercially available formulation. The separation was successfully achieved on silica gel F254, utilizing a solvent system composed of Toluene: Ethyl Acetate: Methanol: Ammonia (6.0: 2.0: 2.0: 0.1, v/v/v/v). Chromatographic bands were visualized under short-wave ultraviolet light at 217 nm. The proposed technique demonstrated well-defined spots for DAPA and VILG, with retention factor Rf values of 0.54 and 0.28, respectively. The method exhibited good linearity within concentration ranges of 200–1400 ng/band for DAPA and 2000-14000 ng/band for VILG. The developed method was successfully applied to the marketed formulation of tablets containing combined dosage form of DAPA and VILG.