A NEW AND VALIDATED RP-HPLC METHOD FOR CONTEMPORANEOUS ESTIMATION OF VILDAGLIPTIN AND DAPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

A novel, quick, and cost-effective RP-HPLC method was developed and validated according to ICH guidelines Q2(R1) for the contemporaneous estimation of two antidiabetic drugs, Vildagliptin and Dapagliflozin, in bulk and pharmaceutical dosage form. Chromatographic separation was achieved using a Hypersil BDS column (250x4.6,5μm) with 0.01M ammonium acetate buffer, acetonitrile, and methanol in the ratio of 30:30:40 V/V/V as mobile phase. This solution was pumped through the column at a flow rate 0.7 mL/min. The optimized wavelength selected for detection was 225 nm. Vildagliptin and dapagliflozin had retention times of 3.077 minutes and 3.746 minutes, respectively. The two drugs were linear in the range of 40-120 μg/mL and 2-6 μg/mL with regression coefficient (r2) values of 0.9996 and 0.9992 for Vildagliptin and dapagliflozin, respectively. For method precision, % RSD of vildagliptin and dapagliflozin was found to be 0.96 and 1.71, respectively. The % Recovery was found to be 99.89% and 100.31% for vildagliptin and dapagliflozin, respectively. LOD, LOQ for Vildagliptin and Dapagliflozin were found to be 4, 12 μg/mL and 0.2, 0.6 μg/mL respectively. The proposed method is highly sensitive, precise, accurate, and robust. All parameters, including theoretical plates, resolution, tailing factor, andpercent RSD, were within acceptable ranges. Hence, this method was successfully developed and applied for the routine quantification of active pharmaceuticals present in commercial formulations. KEY WORDS: Vildagliptin, Dapagliflozin, HPLC, ICH