MUMBAI, India, Aug. 10 -- Intellectual Property India has published a patent application (202621074695 A) filed by Mr. Harsh Kumar Brahmbhatt; Dr. Mitali Dalwadi; Dr Priyanka Sunil Patil; and Dr. Dipti B. Patel on June 16, 2026, for A Novel Reverse Phase High Performance Liquid Chromatographic (rp-Hplc) Method For Quantitative Estimation Of Azilsartan.

Inventors include Mr. Harsh Kumar Brahmbhatt; Dr. Mitali Dalwadi; Dr Priyanka Sunil Patil; and Dr. Dipti B. Patel.

The application for the patent was published on July 31, 2026, under issue no. 31/2026.

Abstract: The present invention relates to a simple, rapid, accurate, precise, robust and stability-indicating reverse phase high performance liquid chromatographic (RP-HPLC) method for quantitative estimation of Azilsartan in bulk drug substances and pharmaceutical dosage forms. The method employs a C18 reversed phase column and a mobile phase comprising acetonitrile and 0.1% orthophosphoric acid in the ratio of 70:30 (v/v). Chromatographic separation is carried out at a flow rate of 1.0 mL/min with UV/PDA detection at 249 nm. Under the optimized conditions, Azilsartan elutes at a retention time of approximately 3.5 minutes with sharp, symmetrical peaks and excellent system suitability characteristics. The method demonstrates linearity over the concentration range of 5-30 µg/mL with a correlation coefficient of 0.9998, high precision, accuracy, specificity and robustness in accordance with ICH validation requirements. The method further shows low limit of detection and limit of quantification, making it suitable for routine quality control, assay, stability studies and regulatory analysis of Azilsartan in pharmaceutical formulations.

Disclaimer: Curated by HT Syndication.