摘要
目的:建立以反相高效液相色谱法测定依帕司他片中有关物质的方法。方法:色谱柱为HypersilBDSC18,流动相为甲醇-0.2%醋酸(65:35),检测波长为285nm,流速为1.6mL.min-1,进样量为20μL。结果:有关物质与主药分离良好,3批样品中有关物质含量均为0.1%。结论:本方法快捷、简便、准确,可用于考察该制剂生产、贮藏、稳定性试验过程中的杂质变化情况。
OBJECTIVE： To establish a RP - HPLC method for the determination of related substances in epalrestat tablets. METHOD ： The determination was performed on Hypersil BDS C18 column, with mobile phase consisted of methanol - 0.2% acetic acid （65 ： 35）. The detection wavelength was set at 285 nm. The flow rate was 1.6 mL · min^-1 and the injection volume was 20μL. RESULTS： The separation was good between the related substances and epalrestat. The contents of the related substances in 3 batches of samples were all stood at 0.1%%. CONCLUSION： The method is quick, simple and accurate, and suitable for quality control of epalrestat tablets.
出处
《中国药房》
CAS
CSCD
北大核心
2008年第22期1736-1737,共2页
China Pharmacy
