摘要
A stability-indicating RP-HPLC method was developed and validated lbr the determination of Rufinamide in tablet dosage forms using C 18 column （250 mm x 4.6 mm, 5 μm） wilh mobile phase consisting of water acetonitrile （40：60, v/v） with a [low rate of 0.8 mL/min （UV detection 215 nm）. Linearity was observed over the concentration range 1.0 200 μg/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. Rufinaraide is more sensitive towards acidic degradation. The method was validated as per ICH guidelines.
A stability-indicating RP-HPLC method was developed and validated lbr the determination of Rufinamide in tablet dosage forms using C 18 column （250 mm x 4.6 mm, 5 μm） wilh mobile phase consisting of water acetonitrile （40：60, v/v） with a [low rate of 0.8 mL/min （UV detection 215 nm）. Linearity was observed over the concentration range 1.0 200 μg/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. Rufinaraide is more sensitive towards acidic degradation. The method was validated as per ICH guidelines.
