双嘧达莫片中有关物质测定方法的研究  

Determination of the related substances of dipyridamole tablets by HPLC

作　　者：薛晓会 王中林 张小折 XUE Xiaohui;WANG Zhonglin;ZHANG Xiaozhe(Pingdingshan Institute For Food and Drug Control, Henan 467000,China)

机构地区：[1]平顶山市食品药品检验所

出　　处：《中国药品标准》2019年第3期247-250,共4页Drug Standards of China

摘　　要：目的:建立双嘧达莫片中有关物质的方法。方法:采用高效液相色谱法,色谱柱为AgilentXDB-C18(4.6mm×250mm,5μm),流动相为0.1%磷酸氢二钠溶液(用磷酸调节pH值至4.6)-甲醇(25∶75),检测波长为288nm,流速1.0mL·min^-1。结果:双嘧达莫与其降解产物在该色谱条件下能够有效分离。结论:所建方法简便,专属性强,可以用于双嘧达莫片中有关物质的测定。Objective:To establish an HPLC method for determination of the related substances of dipyridamole tablets. Methods:The HPLC was performed in XDB-C18 column (4.6 mm×250 mm,5 μm) under the elution of 0.1% disodium hydrogen phosphate solution (adusting pH to 4.6 with phosphoric acid)-methanol (25 ∶ 75). The detection wavelength was 288 nm and the flow rate was1.0 mL·min -1 . Results:Dipyridamole and its degraded products could be separated effectively under the established chromatographic condition. Conclusion:The established method is simple and reliable. It can be used to determine the related substances of dipyridamole tablets.

关 键 词：高效液相色谱法 双嘧达莫片 有关物质 

分 类 号：R921.2[医药卫生—药学]