REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FINERENONE BY RP HPLC

Tamilselvi N.*, Hemalatha K. K., Arundathi P. and Allen D.

ABSTRACT

Finerenone, a novel non
steroidal mineralocorticoid receptor antagonist, has gained significant att ention for the
treatment of chronic kidney disease and heart failure in patients with type 2 diabetes. The accurate quantification of
finerenone in pharmaceutical formulations and biological matrices is crucial for ensuring its quality, efficacy, and
safet y. Reverse phase high performance liquid chromatography (RP HPLC) has emerged as a preferred analytical
technique owing to its robustness, sensitivity, and reproducibility. This review highlights the strategies employed in
the development and optimization of RP HPLC methods for finerenone analysis, covering critical parameters such
as mobile phase composition, column selection, detection wavelength, and system suitability criteria. Method
validation aspects, including specificity, linearity, accuracy, preci sion, limit of detection (LOD), limit of
quantification (LOQ), and robustness, are thoroughly discussed in accordance with ICH guidelines. Additionally,
the review emphasizes the challenges encountered during method development and offers insights into fut ure
perspectives for enhancing the analytical performance for finerenone assessment.

Keywords: Finerenone, RP HPLC, Accuracy, ICH Guidelines.