Abstract
A stability-indicating RP-HPLC method was developed and validated for the determination of Rufinamide in tablet dosage forms using C 18 column (250mm×4.6mm, 5μm) with mobile phase consisting of water–acetonitrile (40:60, v/v) with a flow rate of 0.8mL/min (UV detection 215nm). Linearity was observed over the concentration range 1.0–200μg/mL (R2=0.9997) with regression equation y=113190 x+63053. Rufinamide was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. Rufinamide is more sensitive towards acidic degradation. The method was validated as per ICH guidelines.
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