Simultaneous Estimation of Abiraterone and Niraparib in Pharmaceutical Formulation by RP HPLC Method

Abstract

An isocratic reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous quantitative determination of Abiraterone (ABI) and Niraparib (NIR) in combined pharmaceutical dosage forms. Chromatographic separation was achieved on an Inertsil C-18 column (250 × 4.6 mm, 5 µm particle size) using a mobile phase composed of Acetonitrile, Methanol, and  Triethylamine buffer (pH adjusted to 3 with o-phosphoric acid) in the ratio of 25:35:40 (v/v). The flow rate was maintained at 1.0 mL/min, and detection was carried out at 250 nm. The retention times for ABI and NIR were 3.4 min and 4.5 min, respectively. The method was validated for linearity, accuracy, precision, robustness, specificity, limit of detection (LOD), and limit of quantification (LOQ). The calibration curves showed excellent linearity with correlation coefficients of 0.9998 for ABI (range 5–25 µg/mL) and 0.9997 for NIR (range 2–10 µg/mL). This sensitive, rapid, and robust method was successfully applied to quantify ABI and NIR in combined pharmaceutical tablet formulations, offering a suitable approach for routine quality control analysis.