Abstract

THE DEVELOPMENT AND VALIDATION OF A NOVEL RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ABIRATERONE AND NIRAPARIB IN BULK AND PHARMACEUTICAL DOSAGE FORMULATIONS

Sajeeda Begum, P. Divya, P. Sridevi, Archana Awasthi*

ABSTRACT

A simple, precise, and robust RP-HPLC method was developed for the simultaneous estimation of Abiraterone (ABNE) and Niraparib (NIPB) using an Altima C18 column (150 × 4.6 mm, 5 µm). Chromatographic separation was achieved with a mobile phase consisting of 0.1% OPA and acetonitrile in a 55:45 (v/v) ratio, delivered at a flow rate of 1 mL/min. Detection was carried out at 234 nm. The retention times of ABNE and NIPB were 2.350 min and 3.044 min, respectively. System suitability parameters were within acceptable limits, with %RSD values of 0.2% for ABNE and 0.8% for NIPB. The method demonstrated excellent accuracy, with recovery values of 99.21% for ABNE and 100.92% for NIPB. Linearity was established with regression equations of y = 36905x + 108959 for ABNE and y = 49978x + 5769 for NIPB. Overall, the developed method is suitable for routine quality control analysis of ABNE and NIPB in pharmaceutical formulations.

Keywords: ABNE, NIPB, RP-HPLC.