Journal of Bioequivalence & Bioavailability

High performance liquid chromatographic method for the determination of Rufinamide in tablets

3^rd World Congress Bioavailability & Bioequivalence

March 26-28, 2012 Marriott Hotel & Convention Centre, Hyderabad, India

S. Pavani, M. Mathrusri Annapurna, B. Sai Pavan Kumar and L. Srinivas

Posters: J Bioequiv Availab

Abstract:

R ufinamide is an antie pileptic drug used as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults. Lennox-Gastaut syndrome consists of a variety of treatment-resistant seizures and is most common among paediatric patients. Rufinamide is chemically known as 1- [(2, 6-difluorophenyl) methyl]-1H-1,2,3- triazole-4 carboxamide with molecular formula C 10 H 8 F 2 N 4 O and molecular weight 238.19 g/mol. An isocratic RP-HPLC method was proposed for the determination of Rufinamide in pharmaceutical formulations (Tablets). Isocratic elution was performed using water and acetonitrile as mobile phase. The overall run time was 10 min. and the flow rate of the mobile phase was 0.8 mL/ min. with UV detection at 215 nm. 20 μL of sample was injected into the HPLC system. In the present work chromatographic separation was achieved by using a C-18 (250mm ? 4.6mm i.d., 5 μm particle size) column of Shimadzu Model CBM-20A/20 Alite, equipped with SPD M20A prominence photodiode array detector, maintained at 25 ?C. Linearity was observed in the concentration range of 1?200 μg/mL (R 2 = 0.9997) and the method was validated as per ICH guidelines. The RSD for intra-day and inter-day precision were found to be less than 2 %. The percentage recovery was in good agreement with the labeled amount in the pharmaceutical formulations and the method is simple, precise, accurate and robust for th e determination of Rufinamide.