
doi: 10.1002/chir.70052
pmid: 40875512
ABSTRACTThe enantiomeric purity of Finerenone (FIN), a novel therapeutic for chronic kidney disease (CKD), is a critical quality attribute for ensuring patient safety. This study reports the first chiral HPLC method for the simultaneous determination of FIN and its enantiomer, developed and validated using a rigorous analytical quality by design (AQbD) framework. The method employs a CHIRALPAK AD‐H column with an isocratic mobile phase of n‐hexane: ethanol (62:38, v/v). Optimized conditions provide excellent baseline resolution (Rₛ = 3.5) in under 10 min. The method was validated using accuracy profiles, demonstrating high performance with limits of quantification established at 340 μg mL−1 for FIN and 0.40 μg mL−1 for its 4R enantiomer. The AQbD approach successfully defined a robust method operable design region (MODR) to ensure consistent performance. Furthermore, a multimetric sustainability evaluation confirmed the method's favorable eco‐profile, achieving a Grade Index (BAGI) score of 77.5 and Red‐Green‐Blue 12 (RGB12) score of 80.8. This work provides a reliable, robust, and eco‐conscious analytical tool essential for the quality control of FIN formulations.
Adenosine Triphosphate, Drug Design, Calibration, Stereoisomerism, Naphthyridines, Chromatography, High Pressure Liquid
Adenosine Triphosphate, Drug Design, Calibration, Stereoisomerism, Naphthyridines, Chromatography, High Pressure Liquid
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