Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for the Simultaneous Estimation of Dapagliflozin and Sitagliptin in Tablet

This study developed and validated a robust UV spectrophotometric and RP-HPLC method for the simultaneous estimation of dapagliflozin and sitagliptin in tablets, adhering to ICH guidelines. UV analysis identified λmax at 223 nm (dapagliflozin) and 267 nm (sitagliptin). The concentration ranges employed to assess linearity for dapagliflozin, and sitagliptin were 5-25 µg/ml, and 25-125 µg/ml, achieving linearity with R² 0.999 and accurate recovery rates in range of 98–102%. Assay was found to be 106.4 for dapagliflozin and for 102.8 sitagliptin. RP-HPLC employed a Phenomenex Luna LC C18 (150mmX4.6mm,5µm) column with acetonitrile: methanol: water (25:35:40) as the mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 215 nm retention time of dapagliflozin and sitagliptin was found to be 7.1 and 4.9 min. The method demonstrated linearity for dapagliflozin (4–20 µg/ml) and sitagliptin (20–100 µg/ml) with R² 0.999, and %RSD 2% for precision. The % recovery of spiked sample was 100% (dapagliflozin) and 98.5% (sitagliptin). Assay results for a marketed formulation revealed 90% and 104.3% of labelled amounts for dapagliflozin and sitagliptin, respectively, ensuring compliance with pharmaceutical standards. Both methods were precise, accurate, and robust, suitable for routine quality.