Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN BULK AND TABLET DOSAGE FORM

Suraj Nagwanshi*, Smita Aher and Rishikesh Bachhav

ABSTRACT

A simple, sensitive and accurate Stability Indicating RP-HPLC method has been developed for the determination of Dapagliflozin in bulk and formulation. The λmax of the Dapagliflozin was found to be 285nm in Methanol : Phosphate buffer (50:50) pH 4.0. The method shows high sensitivity with linearity 2-10 μg/ml (regression equation: y = 791514x - 428583; r2 = 0.9992). The various parameters according to ICH guidelines and USP are followed for validating and testing of this method. The Detection limit and quantitation limit were found to be 0.0437 μg ml –1 and 0.1326 μg ml–1 respectively. The % assay of Forxiga 10 (Macleod pharmaceutical) was found to be 99.71%. The force degradation study were employed on five conditions i.e. Acidic, Alkaline, Oxidative, Thermal and Photolytic degradation. The degradation products produced during the stability study were well separated from the pure drug signifying the specificity of developed procedure. The major degradation of drug was found to be in alkali and peroxide stress condition. The results demonstrated that the procedure is accurate, specific and reproducible (RSD <2%), and also being simple, cheap and less time consuming and appropriate for the determination of Dapagliflozin in bulk and tablet dosage form.

Keywords: Dapagliflozin, HPLC method, Force Degradation Study.