Validated stability indicating reversed-phase high-performance liquid chromatography (RP-HPLC) for the estimation of FINERENONE in Pharmaceutical tablet dosage form

Abstract

Abstract An RP-HPLC method was developed and validated for the estimation of Finerenone in the tablet dosage form. Stability indicating nature of the method was established by conducting forced degradation studies Niacinamide was used as an Internal Standard (I.S) to make the method more accurate and precise. The separation was achieved on Hemochrom C18 (25m, 4.6mm, 5µm) analytical column (250 mm × 4.6 mm i.d.5µm) using 0.1% Trifluoro acetic Acid: Acetonitrile (70:30) as mobile phase and at a flow rate of 1.0 mL/min. Detection of Finerenone was carried out at 252nm. The total chromatographic analysis time per sample was about 10.0 min with Finerenone eluting at a retention time of about 4.17 min. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. Validation studies demonstrated that the method is simple, specific, rapid, reliable, and reproducible. The standard curve was linear over the concentration range of 5–45 µg/mL with R2 close to one (0.9996). The limit of detection (LOD) and limit of Quantitation (LOQ) were determined for Finerenone. The developed method was successfully applied for the quantitative analysis of Finerenone in the pharmaceutical dosage form. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the determination of the Finerenone in the Pharmaceutical dosage form.