Analytical Method Development and Validation of Stability Indicating Assay of Abiraterone Acetate and Prednisone by HPLC method

Abstract

The NP-HPLC method was developed and validated for the simultaneous determination of combination Abiraterone acetate and Prednisone and its stability indicating profile.Separation was achieved on T a r g e t s il l C 1 8 , ( 4 . 6 mm x 1 2 5 mm o f 3 μ m) column by using a mobile phase A consisted of water and glacial acetic acid in the ratio of (1000:1ml) %v/v and mobile phase B acetonitrile (500ml) with gradient program at a flow rate of 1.8ml/min. The detection wavelength was carried out by UV detector at 248nm. The Retention time was found to be 1.12 min and 9.53 min for Prednisone and Abiraterone acetate. The Abiraterone acetate and Prednisone over linearity in the range of 75% to 125% and recovery were found to be 95.2% and 96.7%. The Abiraterone acetate and Prednisone was subjected to stress condition of acid hydrolysis, alkali hydrolysis, peroxide oxidation, thermal degradation and UV degradation. It is stable in acid, peroxide and UV degradation. Drug was found to be degrading in alkaline and thermal degradation. The mass balance was found from 90% to 110%, thus proving the stability-indicating power of the method. The developed method was validated system suitability, linearity, accuracy and precision .Results of each parameter meet with its acceptance criteria. Hence the method will be useful for routine assay analysis.