MUMBAI, India, Sept. 22 -- Intellectual Property India has published a patent application (202641106483 A) filed by Marri Laxman Reddy Institute Of Pharmacy on September 03, 2026, for Stability-Indicating Rp-Hplc Method For Simultaneous Estimation Of Avutometinib And Defactinib.
Inventors include Dr. Rakam Gopi Krishna; Chippalapally Samatha; Dr. Arunabha Mallik; Dr. Gangu Sreelatha; Dr. Gali Haritha; and Shweta Nayak.
The application for the patent was published on September 18, 2026, under issue no. 38/2026.
Abstract: A stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method is provided for simultaneous quantitative estimation of Avutometinib and Defactinib in bulk drug substances and pharmaceutical dosage forms. Separation is achieved within 5 minutes on a SunFire C18 column (250 mm × 4.6 mm, 5 µm) using 0.1% orthophosphoric acid aqueous solution and acetonitrile (60:40, v/v) at 1.0 mL/min, with detection at 210 nm, a column temperature of 30°C, and an injection volume of 10 µL. Avutometinib and Defactinib elute at approximately 2.142 and 2.691 minutes, respectively. Mean recoveries are 99.45% and 99.48%, with LOD values of 0.01 and 0.76 µg/mL and LOQ values of 0.02 and 2.30 µg/mL, respectively. Stress studies demonstrate quantitative determination under acidic, alkaline, oxidative, thermal, hydrolytic, and photolytic conditions. The method is suitable for routine assay and stability assessment.
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