Analytical Method Development and Validation Protocol for Antiepileptic Agent – Rufinamide

Abstract

This study developed and validated a new, sensitive, appropriate, clear, accurate, and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for determining Rufinamide in bulk medication and tablet formulation. The separation was performed using an HPLC method with a UV detector and Openlab EZ chrome workstation programme, Kromasil C18, 250 mm X 4.6mm ID, 5 μm column, Methanol: 0.025% TFAA (60:40%V/V) was pumped at a flow rate of 1.0 mL/min and detected at 212 nm. The new RP-HPLC method resulted in a 3.22minute retention time for Rufinamide, which was optimized by trial and error. Over a concentration range of 0.5-7.5 μg/mL, the linearity of the established method was confirmed with a correlation coefficient (r2) of 0.99994. The precision of the approach was determined to have a percentage RSD of less than 2.0 percent. The % recoveries were found to be within the acceptable range. The LOD and LOQ were determined to be 0.10 ug/mL and 0.31 ug/mL, respectively. The developed and validated RP-HPLC system takes less time and can be used in the industry for routine quality control/analysis of bulk drug and marketed Rufinamide products.