Development and validation of a stability indicating RP-HPLC method for the determination of Rufinamide  

作　　者：B.Sai Pavan Kumar M.Mathrusri Annapurna S.Pavani 

机构地区：[1]Department of Pharmaceutical Analysis & Quality Assurance,GITAM Institute of Pharmacy,GITAM University

出　　处：《Journal of Pharmaceutical Analysis》2013年第1期66-70,共5页药物分析学报（英文版）

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.

关 键 词：RUFINAMIDE Reversed-phase HPLCIsocratic elution VALIDATION STABILITY-INDICATING 

分 类 号：R742.1[医药卫生—神经病学与精神病学]