MUMBAI, India, July 13 -- Intellectual Property India has published a patent application (202641083204 A) filed by Marri Laxman Reddy Institute Of Pharmacy on July 07, 2026, for A Novel Stability-Indicating Rp-Hplc Method For The Quantitative Estimation Of Gepotidacin In Bulk Drug And Pharmaceutical Dosage Forms.
Inventors include Dr. Gangu Sreelatha; Dr. Arunabha Mallik; A Akshay; B Sruthi; K Siddu; Heena Begum; Md Sohail Pasha; Dr G Haritha; P Sri Jyothi; and M Bindu.
The application for the patent was published on July 10, 2026, under issue no. 28/2026.
Abstract: The present invention relates to a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for quantitative estimation of gepotidacin in bulk drugs and pharmaceutical dosage forms. Chromatographic separation was achieved using a Waters Symmetry Shield RP-18 column (150 x 4.6 mm, 3.5 µm particle size) with a mobile phase consisting of acetonitrile and water pH-2.5/OPA in the ratio of 30:70 (v/v) at a flow rate of 1 ml/min. Detection was carried out at 218 nm, and the retention time of Gepotidacin was approximately 2.254 minutes. The method exhibited linearity in the concentration range of 25–150 µg/ml. The developed method was validated according to ICH guidelines and demonstrated excellent precision, accuracy, robustness, and sensitivity with an LOD of 0.6 µg/ml and an LOQ of 2.0 µg/ml. Forced degradation studies strictly confirmed the stability-indicating capability of the method.
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