首次采用高效液相色谱串联质谱技术建立了快速鉴定E型马来酸桂哌奇特原料药中Z型异构体杂质的新方法.以20％乙腈、80％乙酸铵缓冲溶液(pH=4.0)为流动相,通过高分辨电喷雾串联质谱在线检测,获得相关的色谱和质谱信息.本法能在无对照品情况下,快速准确地分离鉴定马来酸桂哌奇特原料中的Z/E异构体.%A new method for identifying Z isomer impurity from E cinepazide maleate bulk drug was established by HPLC-MSMS firstly. The mobile phase was acetonitrile 20% and ammonium acetate buffer solution 80% (pH =4.0) , and the eluent was detected by HPLC-MSMS. The method was quick and accurate in separating and identifying the Z isomeric impurity in raw drug material of E cinepazide maleate without control.
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