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目的:建立以HPLC法测定马来酸桂哌齐特注射液有关物质的含量的测定方法。方法:色谱柱为迪马-ODS,流动相为乙腈-0.05mol.L-1磷酸氢二钠溶液(40∶60),检测波长230nm,流速为1.0mL·min-1,进样量为20μL。结果:马来酸桂哌齐特在200～800mg·mL-1(r=0.9999)范围内线性关系良好,有关物质与主峰分离良好,3批样品中有关物质含量均小于1%。结论:本方法简便、快速、准确、重复性好,可用于该制剂的有关物质的含量测定。
Objective: To establish a HPLC method for determination of cinepazide maleate injection related substances content determination method. Methods: The chromatographic column was Dima-ODS. The mobile phase was acetonitrile-0.05mol.L-1 disodium hydrogen phosphate solution (40:60), the detection wavelength was 230nm, the flow rate was 1.0mL · min-1 and the injection volume was 20μL . Results: Cinepazide maleate showed good linearity in the range of 200-800 mg · mL-1 (r = 0.9999). The related substances were well separated from the main peak, and the content of related substances in the three batches of samples was less than 1%. Conclusion: The method is simple, rapid, accurate and reproducible. It can be used for the determination of related substances in this preparation.