Validated RP – HPLC Method for Simultaneous Estimation of Dapagliflozin and Saxagliptin Hydrochloride in Tablet Dosage Form

Abstract

A new, precise, rapid, accurate RP – HPLC method was developed and validated for simultaneous estimation of Dapagliflozin and Saxagliptin Hydrochloride in bulk and in tablet dosage form. The samples were isocratically eluted by using Hypersil BDS C18 (250 mm × 4.6 mm) 5μm column with a mobile phase mixture of Phosphate buffer (pH 4.5) : Methanol in the ratio of 85:15 v/v at a flow rate of 1 ml/min and detection wavelength of 222 nm. The retention time of Dapagliflozin and Saxagliptin HCl found to be 4.080 min and 5.343 min. A good linear response was obtained in the concentration range of 10 – 30 μg/ml for Dapagliflozin and 5 – 15 for Saxaglitpin HCl. The correlation coefficient R2 value is found to be 0.998 for Dapagliflozin and 0.993 for Saxaglitpin HCl. The limit of detection (LOD) and limit of quantification (LOQ) of Dapagliflozin were found to be 1.16 μg/ml and 3.52 μg/ml, while those of Saxagliptin HCl were found to be 0.53 μg/ml and 1.62 μg/ml. The method was found to be rapid, sensitive, linear, specific, accurate, precise and economic for estimation of Dapagliflozin and Saxagliptin HCl in marketed tablet dosage forms.