论文部分内容阅读
目的:建立以反相高效液相色谱法测定马来酸桂哌齐特片中有关物质含量的方法。方法:色谱柱为Hypersil ODS2,流动相为0.05mol·L-1磷酸氢二钠溶液(用磷酸调pH至4.5)-乙腈(75∶25),检测波长为230nm,流速为1.0mL·min-1,进样量为20μL。结果:有关物质与主成分分离良好,3批样品中有关物质含量均为0.1%。结论:本方法操作简单、专属性强,可用于该制剂中有关物质的含量测定。
Objective: To establish a method for the determination of related substances in the cinepazide maleate tablets by reversed-phase high performance liquid chromatography. Methods: The chromatographic column was Hypersil ODS2. The mobile phase consisted of 0.05 mol·L-1 sodium phosphate dibasic solution (pH adjusted to 4.5 with phosphoric acid) -acetonitrile (75:25). The detection wavelength was 230 nm and the flow rate was 1.0 mL · min- 1, injection volume of 20μL. Results: The related substances were well separated from the main components, and the content of the related substances in the three batches of samples was 0.1%. Conclusion: The method is simple, specific and can be used for the determination of related substances in the preparation.