Development and Validation of High-Performance Thin Layer Chromatographic Method for the Simultaneous Estimation of Dapagliflozin and Vildagliptin in Fixed-Dose Combination.

Objectives: The objective of this study was to develop a simple, precise, and accurate high-performance thin-layer chromatographic (HPTLC) method for the simultaneous estimation of dapagliflozin (DAP) and vildagliptin (VIL) in a combined pharmaceutical formulation. Managing diabetes often involves using a combination of drugs to better control blood sugar levels. One such effective formulation is combination of DAP, an SGLT2 inhibitor, with VIL, a DPP-4 inhibitor, in a single formulation. To ensure the quality and consistency of these combination products, it is important to have a simple and reliable method for analyzing both drugs simultaneously. Materials and Methods: An aluminium-backed pre-coated silica gel 60 F254 TLC plate was employed as the stationary phase. The mobile phase consisted of toluene, methanol, and ethyl acetate in a volumetric ratio of 5:3:2. Prior to plate development, the chamber was saturated with the mobile phase for 20 minutes. Detection was carried out at 210 nm, selected based on the isosbestic point of the analytes. Results: The developed method successfully separated the analytes with retardation factor values of 0.57±0.02 for DAP and 0.26±0.02 for VIL. The method exhibited linearity in the concentration ranges of 0.6 to 1.4 μg per band for DAP, with a correlation coefficient (r²) of 0.997 and 6 to 14 μg per band for VIL, with an r² of 0.998. The limit of detection was found to be 0.02 μg/band for DAP and 0.19 μg/band for VIL. Similarly, the limit of quantification was determined to be 0.07 μg/band for DAP and 0.58 μg/band for VIL. Conclusion: The proposed HPTLC method allows for the simultaneous estimation of DAP and VIL with high accuracy, precision, and sensitivity. Owing to its satisfactory analytical performance, the method is suitable for routine quality control of combined dosage forms containing DAP and VIL.