Estimation of Dapagliflozin in Pure and Marketed Formulation by Validated Reverse Phase-High Performance Liquid Chromatographic Method

Abstract

Dapagliflozin is a highly selective, orally active and reversible inhibitor of the human sodium glucose cotransporter 2 (SGLT2). The dapagliflozin is a diabetic drug which is used with proper diet and exercise in adults with type 2 diabetes to improve the glycemic control. The aim of this study is to develop a rapid, precise and accurate RP-HPLC method for estimation of dapagliflozin in bulk and formulation as per ICH guidelines. The chromatography was carried on Sunsil C18 (150 X4.5mm, 5µ) column HPLC (Water's) using a mixture of methanol and water at different ratios and finally optimized with 85:15 v/v as mobile phase with flow rate 1.0ml/min at 225nm. The correlation regression is found to be 0.999. The retention time was found to be 2.74min. The accuracy of the present method was evaluated at 50%, 100% and 150%. The recoveries of dapagliflozin API and tablet were found to be in the range of 98.5%-100.6%. Precision studies were carried out and the relative standard deviation values were less than two. The method was found to be robust. The limit of detection and limit of quantification were determined as 0.011µg/ml and 0.034µg/ml. The proposed method was found to be rapid, precise, accurate and robust and can be used for the estimation of dapagliflozin in API and Pharmaceutical dosage form.