DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF NIRAPARIB AND ABIRATERONE ACETATE IN PHARMACEUTICAL DOSAGE FORMS

Abstract

A simple, accurate, and precise reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Niraparib and Abiraterone Acetate in tablet dosage forms. The separation was achieved on a BDS C18 column (250 mm × 4.6 mm, 5 μm particle size) using a mobile phase consisting of sodium dihydrogen phosphate buffer and acetonitrile in the ratio of 40:60 v/v, delivered at a flow rate of 1.0 mL/min. The detection wavelength was set at 234 nm, and the retention times for Niraparib and Abiraterone Acetate were found to be 2.8 minutes and 7.6 minutes, respectively. The method was validated according to ICH guidelines and demonstrated excellent linearity, precision, accuracy, robustness, and system suitability. This method proved to be efficient and reliable for routine analysis of the combination product in quality control laboratories.