Vaishnavi KARJKHEDE, Ganesh GAJELI, Supriya MHAMANE, Divya BIRAJDAR
Journal of Research in Pharmacy - 2026;30(3):909-920
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 lambdamax at 223 nm (dapagliflozin) and 267 nm (sitagliptin), HCl buffer (pH-1.2) as a solvent. 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 results in range of 98-102%. Assay was found to be 104.4 for dapagliflozin and for 102.8 sitagliptin. RP-HPLC separation 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 1.00 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 96% 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.
