Development of Validated Stability-Indicating RP-HPLC Method Based on Forced Degradation Studies for the Quantitative Analysis of Rucaparib

Abstract

A simple, rapid, precise, accurate, and stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative determination of rucaparib in tablet dosage forms. Chromatographic separation was achieved using a C18 analytical column with an optimized mobile phase under isocratic elution, providing efficient peak resolution, acceptable retention time, and symmetrical peak characteristics. The developed method was validated according to International Council for Harmonisation (ICH) guidelines with respect to specificity, linearity, accuracy, precision, robustness, limit of detection (LOD), and limit of quantification (LOQ). Excellent linearity was obtained over the selected concentration range with a correlation coefficient greater than 0.999. The method demonstrated satisfactory precision (%RSD < 2%), high recovery, and robustness against deliberate variations in chromatographic conditions. Forced degradation studies were performed under acidic, alkaline, oxidative, thermal, photolytic, and neutral hydrolytic stress conditions to evaluate the stability-indicating capability of the method. Rucaparib exhibited degradation under selected stress conditions while the drug peak remained well resolved from all degradation products, confirming the specificity and stability-indicating nature of the method. Peak purity analysis further established the absence of co-eluting degradation products. The validated RP-HPLC method is reliable, sensitive, and suitable for routine quality control, stability testing, and assay of rucaparib in pharmaceutical tablet formulations.