MUMBAI, India, Oct. 26 -- Intellectual Property India has published a patent application (202641123425 A) filed by Kvsr Siddhartha College Of Pharmaceutical Sciences on October 15, 2026, for An Aqbd-Driven Rapid Rp-Hplc-Pda Method For Quantification Of Finerenone Using Central Composite Design.
Inventors include Kvsr Siddhartha College Of Pharmaceutical Sciences; Talluri Sarada Mrinalini; Gangesetty Hema Sree; Ravulapati Anusha; Goga Bhavani; Kondeti Durga Prasad; Janaki Ram K; Mohammad Salar Ahamad; Ch. Hemalatha; and Vemulapalli Bhanu Vyshnav Sai.
The application for the patent was published on October 23, 2026, under issue no. 43/2026.
Abstract: The present invention relates to an analytical quality-by-design driven RP-HPLC-PDA method for quantification of Finerenone in bulk material and tablet formulations. The method employs a Symmetry Shield RP-18 column of 150 × 4.6 mm and 3.5 µm particle size. Chromatographic separation is performed in isocratic mode using acetonitrile and 0.1% perchloric acid in a ratio of 27:73 by volume at a flow rate of 1.14 mL/min, with PDA detection at 234 nm and a run time of five minutes. Acetonitrile proportion and flow rate are evaluated as critical method variables through a thirteen-run rotatable central composite design, while retention time, theoretical plate count and tailing factor are used as analytical responses. Numerical optimization identifies approximately 27.071% acetonitrile and 1.141 mL/min as optimized conditions. The finalized method provides a retention time of 1.617 minutes, theoretical plate count of 16,181 and tailing factor of 0.91. The method is linear over 25–150 µg/mL with R² of 0.99989. The method is further evaluated for specificity, precision, accuracy, robustness, sensitivity, tablet assay and forced degradation under multiple stress conditions. The method provides a rapid analytical procedure for Finerenone quantification in bulk material and tablet formulations.
Disclaimer: Curated by HT Syndication.
