MUMBAI, India, May 1 -- Intellectual Property India has published a patent application (202641049680 A) filed by Anurag University, Hyderabad, Telangana, on April 18, for 'system and method for stability-indicating uhplc analysis of difelikefalin and its degradation products.'
Inventor(s) include Dr. Srinivas Bathini; and S R Gangadhar Koppineni.
The application for the patent was published on May 1, under issue no. 18/2026.
According to the abstract released by the Intellectual Property India: "The present invention discloses a stability-indicating reverse-phase ultra-high-performance liquid chromatography system (100) for quantitative assay, related substances profiling, and degradation product identification of Difelikefalin and its pharmaceutically acceptable salt forms. The system comprises a sample preparation module (101), a method optimization module (102), a reverse-phase UHPLC analysis module (103), a forced degradation evaluation module (104), a peak purity and assay module (105), a validation and mass balance module (106), an LC-MS degradant identification module (107), and a reporting module (108). The system enables chromatographic separation of Difelikefalin from related impurities and degradation products under acidic, alkaline, oxidative, thermal, and photolytic stress conditions. Further, LC-MS-based characterization provides tentative structural identification of major degradants."
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