STABILITY INDICATING LIQUID CHROMATOGRAPHIC METHOD FOR THE QUANTITATIVE DETERMINATION OF RUFINAMIDE IN PHARMACEUTICAL DOSAGE FORMS

Abstract

A selective, specific and sensitive stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Rufinamide in tablet dosage forms. Reversed-phase chromatography was performed on Shimadzu Model CBM-20A/20 Alite, equipped with SPD M20A prominence photodiode array detector using C18 column (250 mm × 4.6 mm, 5 μm) with a flow rate of 1.0 mL/min.  Detection wavelength was 210 nm and temperature was 30°C.  Linearity was observed in the concentration range of 0.01–160 μg/mL with regression equation y = 112887 x + 35285 with correlation coefficient of 0.9998. The LOD and LOQ were found to be 0.0086 μg/mL and 0.0028 μg/mL respectively. The percentage relative standard deviation in precision and accuracy studies was found to be less than 2%. Rufinamide was subjected to stress conditions of degradation in aqueous solutions including acidic, alkaline, oxidation, photolysis and thermal degradation and it was found that the drug is highly resistant towards all degradations as the decomposition was less than 1.5%. The developed method was validated with regard to linearity, accuracy, precision, selectivity and robustness and the method was found to be precise, accurate, linear and specific.  As the proposed LC method achieved satisfactory resolution between Rufinamide, its degradation products, intermediate product possibly present in Rufinamide drug substance and other impurities in the end product before refining in the final step of synthetic process, it can be employed as a stability indicating one, used for the synthetic process control and determination of Rufinamide in pharmaceutical preparations.

Keywords: Rufinamide, Isocratic elution, RP-HPLC, Validation, Stability-indicating, LOD, LOQ.