ABSTRACT

The objective of this study is to develop Simple, rapid, and sensitive RP-HPLC for Finerenone in tablet dosage form by QbD approach. In this method, Finerenone was estimated using C18 Sunfire column (250×4.6 mm, 4.8 ?m) and 0.01N KH2:PO4: methanol (61.2:38.8 % V/V) as mobile phase and flow rate 1 mL/min which are optimized using Design-Expert software. Method was developed at 272 nm detection wavelength. The retention time was found to be 3.051min. The proposed method was successfully applied to the determination of Finerenone in tablet dosage form. High linearity of developed method was confirmed over concentration range of (5-30) ?g/mL and correlation co-efficient is 0.9994. The recovery was found to be 100.68 %; LOD was found to be 0.31 ?g/mLand LOQ was found to be 0.95 ?g/mL. There was no interference of excipient and degradation product in retention time, so the method was specific. Analytical parameters such as precision, accuracy, LOD, LOQ and robustness were determined according to ICH guidelines. Keywords: Finerenone, QbD Approach, Method development, RP-HPLC, LOD, LOQ
Publication date: 01/09/2026

https://www.ijbpas.com/pdf/2026/September/MS_IJBPAS_2026_10457.pdf

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https://doi.org/10.31032/IJBPAS/2026/15.9.10457