Stability Indicating Method Development and Validation for Determination of Abiraterone in Bulk and Pharmaceutical Dosage Forms by RP-HPLC

Abstract

A simple, Precised, Accurate method was developed for the estimation of Abiraterone by RP-HPLC technique. Chromatographic conditions used are stationary phase Discovery C18 150mm x 4.6 mm, 5m ,Mobile phase 0.01% KH2PO4:Acetonitrile  in the ratio of 60:40 and flow rate was maintained at 1.1 ml/min, detection wave length was 235 nm, column temperature was set to 30^oC and diluent was mobile phase Conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25% to150 % levels, R² value was found to be as 0.999. Precision was found to be 0.6 for repeatability and 0.2for intermediate precision. LOD and LOQ are 0.953µg/ml and 2.888µg/ml respectively. By using above method assay of marketed formulation was carried out 99.90% was present. Degradation studies of Abiraterone were done, in all conditions purity threshold was more than purity angle and within the acceptable range.