STABILITY INDICATING RP-HPLC METHOD FOR THE DEVELOPMENT AND VALIDATION OF FINERENONE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Abstract

Finerenone in pharmaceutical formulation. The chromatogram was analysed using a Sunfire C18 column (4.6 mm x 250 mm, 5 μm). Mobile phase including 0.1% OPA: Methanol, in a 60:40 ratio, was pumped through the column at a flow rate of 1.0 ml/min. The temperature was sustained at 30°C. The chosen optimised wavelength was 219.0 nm. The retention time of Finerenone was determined to be 2.262 minutes. The %RSD of Finerenone was determined to be 0.3%. The relative standard deviation (RSD) of the method precision for Finerenone was determined to be 0.3%. %The recovery for Finerenone was determined to be 100.03%. The limits of detection (LOD) and quantification (LOQ) values derived from the regression equation for Finerenone are 0.08 and 0.24, respectively. The regression equation for Finerenone is expressed as y = 23931x + 2701.6. The retention periods and run times were reduced, indicating that the suggested approach is straightforward and cost-effective, suitable for frequent quality control testing in industries.