高效液相色谱法测定唑尼沙胺中的有关物质

High Performance Liquid Chromatography Determination of Related Substances of Zonisamide

目的建立唑尼沙胺原料中有关物质的高效液相色谱测定方法。方法采用ODS C18柱(150 mm×4.6 mm,5μm),以甲醇-乙腈-水(20∶17∶63)为流动相;流速:1.0 ml/min;检测波长:241 nm。结果样品中唑尼沙胺与各杂质分离良好;最低检测限为0.25 ng。结论该方法简便、专属性及灵敏度好,可用于唑尼沙胺原料中有关物质的检查。

Objective To establish a high performance liquid chromatography method for the determination of related substances of zonisamide.Methods The chromatographic column was ODS C18（150mm×4.6mm,5μm）.The mobile phase consisted of methanol：acetoni-trile-water（20∶17∶63）.The flow rate was 1.0ml/min,and the detection wavelength was 241nm.Results Zonisamide was separated from the impurities thoroughly.The LOD was 0.25ng for zonisamide.Conclusion The method is simple,specific,sensitive and suitable for the determination of related substances of zonisamide.