Analytical Method Development and Validation for The Simultaneous Estimation of Topiramate and Rufinamide for RP-HPLC Method (Research Article)

Author(s): P. Raj Kumar, M. Shara, M. Mamata*, D. Prabhakar and A. Rajender

Abstract: A new method was established for simultaneous estimation of Rufinamide and Topiramate by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Rufinamide and Topiramate by using Xterra C18 5μm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (55:45%v/v) (pH was adjusted with orthophosphoric acid), detection wave length was 255nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Rufinamide and Topiramate was found in concentration range of 1μg-5μg and 100μg-500μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100% and 100.5%, %RSD for repeatability was.0.2 and 0.4, % RSD for intermediate precision was 0.5 and 0.1 respectively.

PAGES: 155-159  |  128 VIEWS  331 DOWNLOADS