An Isocratic RP-HPLC Method Development and Validation for the Quantitative Estimation of Finerenone in Solid Dosage Forms

Abstract

An accurate, sensitive, precise, quick isocratic reverse phase HPLC (RP-HPLC) method has been developed and validated for quantification of Finerenone in bulk and pharmaceutical tablet dosage forms. With acetonitrile as the organic solvent, the best separation was achieved on a 250 mmx 4.6 mm i.d, 5µ-particle size Inertsil®-Octadecyl-silyl-3V-Reverse-Phase-C18-column with 0.03M Ammonium Acetate in water: Acetonitrile (20:80 v/ v) in the isocratic mode of elution as mobile phase solvent at a speed of 1.0 mL.min−1. UV detection was at 230 nm. Retention time of Finerenone was 10.9 minutes. With a correlation coefficient of about 0.9999, peak-response was obtained as function of concentration over the range of 80 to 240 µg/ ml for Finerenone. Percentage assay of Finerenone was shown to be 109.42 %. Finerenone had a limit of detection of 0.1 µg/ ml and a limit of quantification (LOQ) of 0.3 µg/ ml. The presence of excipients in the formulation had no effect on the assay method. The procedure is appropriate for use in QC- laboratories since it is economical and precise.