Analytical Method Development and Validation for the Estimation of Abiraterone and its Impurity in Pharmaceutical Formulation By RP-HPLC

摘要

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the determination of Abiraterone and its impurity in pharmaceutical dosage form. The column used was Discovery 250 mm × 4.6 mm, 5m., with mobile phase containing buffer and acetonitrile in the ratio of 50: 50 v/v, the flow rate was 1.0 ml/ min and eluent was monitored at 235nm. The retention time for Abiraterone was 4.372 and for impurity it is 3.182. The proposed method was validated and successfully applied to the estimation of Abiraterone and impurity in formulations.