Decipher Ayurveda

Abstract

A sensitive, accurate, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative estimation of Niraparib (NIR) in bulk and pharmaceutical formulations. The analysis was performed using an Agilent 1260 Infinity II HPLC system equipped with a diode array detector (DAD) and a C18 column (250 × 4.6 mm, 5 µm). The mobile phase consisted of 0.2% glacial acetic acid and Acetronitrile in a ratio of 65:30 v/v, delivered at a flow rate of 1.0 mL/min. Detection was carried out at 240 nm with a total run time of 10 minutes. Niraparib exhibited a retention time of 5.2 minutes.
The method was validated according to ICH guidelines. The calibration response was linear over 20–60 µg/mL with an R² of 0.9996. Accuracy studies produced recoveries of approximately 99–101%, while precision studies produced %RSD values below 2%. These results indicate that the method has adequate analytical performance for quantitative estimation.
The forced-degradation study demonstrated separation of niraparib from degradation-related components. Therefore, after experimental confirmation using peak-purity/PDA or equivalent evidence, the procedure can be considered for stability-indicating applications. The developed method is simple, robust, and suitable for routine quality control and stability testing of Niraparib in pharmaceutical preparations.