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

被引：0
|
作者：
B.Sai Pavan Kumar [1 ]
M.Mathrusri Annapurna [1 ]
S.Pavani [1 ]
机构：
[1] Department of Pharmaceutical Analysis & Quality Assurance,GITAM Institute of Pharmacy,GITAM University
来源：
Journal of Pharmaceutical Analysis | 2013年 / 3卷 / 01期
关键词：
Rufinamide; Reversed-phase HPLC; Isocratic elution; Validation; Stability-indicating;
D O I：
暂无
中图分类号：
R742.1 [癫痫];
学科分类号：
1002 ;
摘要：
A stability-indicating RP-HPLC method was developed and validated for the determination of Rufinamide in tablet dosage forms using C 18 column (250 mm 4.6 mm, 5 mm) with mobile phase consisting of water-acetonitrile (40:60, v/v) with a flow rate of 0.8 mL/min (UV detection 215 nm). Linearity was observed over the concentration range 1.0-200 mg/mL (R 2 0.9997) with regression equation y 113190 xt63053. 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.
引用
收藏
页码：66 / 70
页数：5
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