Development And Validation of Rp-Hplc Method For Es-timation of Dapagliflozin In Bulk and Pharmaceutical Dosage Form

Dapagliflozin is a novel inhibitor of renal sodium-glucose cotransporter 2, which allows an insulin- independent approach to improve Type-II diabetes hyperglycemia . It is a C-aryl glucoside derivative and is chemically known as (1s)-1, 5-anhydro-1-C-[4-chloro3-[(4-ethoxyphenyl) methyl] phenyl]-D- glucitol. Empirical formula is C21H25ClO6 and has a molecular weight of 408.9g/mol. The present study indicates a simple, accurate, and precise reverse phase high performance liquid chromatography was developed and validated for the estimation of Dapagliflozin in pharmaceutical dosage form. The mobile phase used was Acetonitrile :Water 75:25v/v. The specifications of the chromatographic system are column C18 (Dimensions: 4.6 x 250 mm), flow rate 1ml/min, detection 285nm and injection volume 10ul and run time 5 min. The retention time was found 3.32min. The linearity curve was in the range of 20-70ppm. The recoveries found to be 96.75 to 103.43 %. The proposed method was validated and successfully applied to the estimation of Dapagliflozin and its dosage form.