Abstract

A NEW HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF DAPAGLIFLOZIN IN TABLET DOSAGE FORM

Narottam Pal*, Tayyaba Mahtab, P. Pravalika Reddy and A. Srinivasa Rao

Abstract

A simple, accurate, rapid and precise isocratic reverse phase high performance liquid chromatographic method has been developed and validated for the determination of Dapagliflozin in tablet dosage form. The chromatographic separation was carried out with a Develosil ODS HG-5 (C18) 15mm x 4.6 mm, 5μm analytical column, a mixture of phosphate buffer : acetonitrile in the ratio of 80:20 as mobile phase, at a flow rate of 1.0 ml/minute maintaining the temperature at 30ºc. UV detection was performed at 292 nm. The retention time was 3.545 minutes for Dapagliflozin. The method was validated according to ICH guidelines and the acceptance criteria of results for accuracy, precision, linearity, robustness, limit of detection, limit of quantification and ruggedness were met in all cases. The % RSD values for Dapagliflozin in precision study was found to be 0.86%. The linearity of the calibration curve for each analyte in the desired concentration range was good (r2>0.999). The high recovery and value of low relative standard deviation confirm the suitability of the method for routine evaluation of Dapagliflozin in pharmaceutical dosage forms.

Keywords: Dapagliflozin, HPLC, Method development, validation.