Simultaneous Estimation and Validation of Dapagliflozin and Saxagliptin in Bulk Drug and Dosage Form by RP-HPLC

A simple, rapid, precise, accurate RP-HPLC method has been developed and validated to estimate Saxagliptin hydrochloride and Dapagliflozin in bulk and in dosage form. The samples were eluated Grace C18 (250mm x 4.6 ID, Particle size: 5micron with mobile phase Methanol: water (pH adjusted to 3 with potassium dihydrogen orthophosphate) (80: 20) at wavelength 225nm. A good linear response was obtained in the range from 10–50μg/mL for Saxagliptin hydrochloride and Dapagliflozin. The method was quantitatively evaluated in terms of linearity, precision, accuracy (recovery), selectivity and robustness as per USP guideline.