Development and Validation of RP-HPLC Method for Simultaneous Estimation of Saxagliptin and Dapagliflozin in Tablets

A simple, accurate, precise and selective RP-HPLC method was developed and validated for simultaneous estimation of Saxagliptin (SAXA) and Dapagliflozin (DAPA) in tablet dosage form. Both drugs were separated on Phenomenex Hyperclone C18 column (250 ×4.6 mm, 5μ) using methanol: 20 mM phosphate buffer (pH3.0) (70: 30, v/v) in an isocratic mode at flow rate of 1 mL/min. Chromatographic determination was carried out at wavelength of 225nm. SAXA and DAPA were eluted at 4.70 and 6.45min, respectively. The method was found linear in the range of 2–12 μg/mL and 4–24 μg/mL for SAXA and DAPA, respectively. The method was validated for linearity, accuracy, precision and selectivity. The developed method can be used for routine analysis of SAXA and DAPA tablets.