MUMBAI, India, May 29 -- Intellectual Property India has published a patent application (202641062317 A) filed by Vignan's Foundation For Science, Technology And Research, Guntur, Andhra Pradesh, on May 16, for 'gradient rp-hplc method for simultaneous resolution and quantification of co-eluting related impurities in fluticasone furoate api.'
Inventor(s) include Ganesh Jerripothula; and Dr. Popuri Ashok Kumar.
The application for the patent was published on May 29, under issue no. 22/2026.
According to the abstract released by the Intellectual Property India: "Fluticasone furoate is second-generation inhaled corticosteroid generally prescribed for asthma, chronic obstructive pulmonary disease and allergic rhinitis. The study discloses a novel, selective, and fully validated gradient reverse-phase high-performance liquid chromatography (RP-HPLC) method for the separation and individual quantification of fluticasone furoate and its pharmacopoeially recognized structurally related impurities. In this study, core technical problem was solved by this invention is the co-elution of Impurities E, F, and G under the existing British Pharmacopoeia reference procedure. The claimed method resolves this problem by employing a phenyl-hexyl 2.7 m porous shell stationary phase in combination with 0.1% trifluoroacetic acid and acetonitrile and methanol (80:20 v/v) organic modifier, operated under gradient conditions at 245 nm and 50 C column temperature. The finalized method achieves complete baseline resolution of fluticasone furoate and its impurities in a single chromatographic run. The method has been validated in full compliance with ICH Q2 (R1) guidelines, demonstrating linearity (r 0.998), limit of detection of 0.015 g/mL, limit of quantification of 0.05 g/mL, precision (%RSD 1.2%), accuracy (90-110% recovery), and robustness under deliberate parameter perturbations."
Disclaimer: Curated by HT Syndication.
