ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ABIRATERONE ACETATE IN PHARMACEUTICAL FORMULATION BY UV AND RP-HPLC

Abstract

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the determination Abiraterone Acetate in pharmaceutical dosage form. The column used was Hypersil ODS C18 (4.6 x 150mm, 5 mm,) in isocratic mode, with mobile phase containing phosphate buffer adjusted the pH-3.0 with orthophosphoric acid and Acetonitrile ratio of (50%:50%) the flow rate was 1.0 mL/ min and eluents was monitored at 254nm. The retention time Abiraterone was 4.858 min. The linearity for Abiraterone was in the range of 10-30 µg/ml respectively. The recovery of Abiraterone was found to be 99.5%, respectively. The proposed method was validated and successfully applied to the estimation of Abiraterone in tablet dosage form. Mass and FTIR analysis performed to determine Abiraterone Acetate in pharmaceutical dosage form.