Development and Validation of RP-HPLC Method for Simultaneous Estimation of Saxagliptin and Dapagliflozin in Tablets More Sayali S., Sonawane Sandeep S.*, Chhajed Santosh S., Kshirsagar Sanjay J. Department of Pharmaceutical Analysis, MET's Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422 003 *Corresponding Author E-mail: sandeeps.iop@gmail.com
Online published on 24 October, 2018. Abstract 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. Top Keywords Dapagliflozin, Saxagliptin, HPLC, Analytical Method Validation. Top |