“RP-HPLC Method Development and Validation ...

“RP-HPLC Method Development and Validation for Estimation of Topiramate in Bulk and Pharmaceutical Dosage Form”

Author Name : Saurabh. V. Patil, Mr. Amitkumar R. Dhankani, Dr. Sunil. P. Pawar, Sameer. D. Suryawanshi

ABSTRACT This research article presents the development and validation of a reverse-phase high-performance liquid chromatography (RP-HPLC) method for accurately estimating Topiramate in both bulk form and pharmaceutical dosage formulations. Topiramate, a widely used anticonvulsant and migraine preventive medication, requires precise analytical methods for quality control and therapeutic monitoring. The methodology involved in this study encompasses several key steps. Firstly, a standard stock solution of Topiramate was prepared by accurately weighing 26.32 mg of Dolutegravir Sodium (equivalent to 25 mg of Dolutegravir) and transferring it into a 50 mL volumetric flask. This stock solution was then diluted with Methanol to achieve a concentration of 500 parts per million (PPM), suitable for subsequent analysis. A series of standard solutions with varying concentrations of Topiramate were also prepared for calibration purposes. To analyse Topiramate in bulk form, samples were prepared by accurately weighing and transferring the required amount of Topiramate into volumetric flasks, followed by dissolution in a suitable solvent system.