MUMBAI, India, Aug. 24 -- Intellectual Property India has published a patent application (202641097223 A) filed by Anurag University on August 12, 2026, for A Method For Stability-Indicating Rp-Hplc Analysis Of Tovorafenib In Bulk Drug And Pharmaceutical Dosage Form.
Inventors include Dr. Dodda Sireesha; and Dr. Vemuluri Padmabhushana Chary.
The application for the patent was published on August 21, 2026, under issue no. 34/2026.
Abstract: ABSTRACT The present invention relates to a method (100) for stability-indicating RP-HPLC analysis of Tovorafenib in bulk drug and pharmaceutical dosage forms. The method (100) comprises selecting Tovorafenib as an analyte (102), selecting an Allsep Anion chromatographic column (104), preparing a mobile phase (106) comprising ammonium phosphate buffer and methanol, and preparing standard and sample solutions (108, 110) of Tovorafenib. The prepared solutions are subjected to chromatographic separation using an RP-HPLC system (112) under optimized conditions including flow rate, detector wavelength, column temperature, and injection volume. The method (100) further comprises system suitability testing (114), validation (116) according to ICH Q2(R1) guidelines, and forced degradation studies (118) under acidic, alkaline, oxidative, thermal, photolytic, and neutral conditions. The developed method (100) effectively separates Tovorafenib from degradation products (120) and provides accurate, precise, robust, rapid, and economical quantitative estimation (122) suitable for pharmaceutical quality control, stability assessment, and routine analysis. The figure associated with the abstract is Fig. 1.
Disclaimer: Curated by HT Syndication.
