Analytical Method Development and Validation of Finerenone in Bulk and Formulation by HPLC

A simple, rapid, precise, accurate, and robust reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative determination of finerenone in bulk drug substance and pharmaceutical tablet formulation. Chromatographic separation was achieved on a C18 column employing an isocratic mobile phase composed of acetonitrile and 10 mM ammonium dihydrogen phosphate buffer (pH 4.5) at a flow rate of 1.0 mL/min, with UV detection at 238 nm. Finerenone exhibited a retention time of 7.24 min. The method was validated as per ICH Q2(R2) guidelines with respect to system suitability, specificity, linearity, accuracy, precision, robustness, and solution stability. Linearity was demonstrated over a concentration range of 50–150% of the working concentration (100.52–301.56 µg/mL), with a correlation coefficient of 1.00. Recovery studies at three spike levels (50%, 100%, and 150%) yielded mean percent recovery of 101.1% (%RSD 0.45), indicating excellent accuracy. Method precision studies showed %RSD of 0.27%, well within the NMT 2.0% acceptance criterion. Standard and sample solutions were stable for up to 65 hours and 58 hours, respectively, at 10°C. Specificity evaluation confirmed no interference from placebo excipients or known process-related impurities (acid impurity, aromatization impurity, dimethyl impurity). The validated method was successfully applied to the assay of marketed tablets and is suitable for routine quality control analysis of finerenone in pharmaceutical manufacturing environments.