HPLC-ELSD/DAD测定阿卡波糖工作参照品的含量

Determination of working reference standard of Acarbose by HPLC-ELSD/DAD

目的研究HPLC测定阿卡波糖工作参照品的含量。方法对国外参考品传递测定和新建的两种检测器测定方法进行对比;通过C18色谱柱反相分离,用DAD检测器、ELSD检测器分别测定阿卡波糖及其相关物质的含量。结果国外参考品传递测定结果为98.9%,DAD检测为99.0%,RSD=0.4%;ELSD检测为98.6%,RSD=1.2%。结论所建方法符合参照品定值要求,结果准确可靠。

OBJECTIVE To develop an HPLC method to determine the content of the working reference standard of Acarbese. METHODS Determination of overseas Acarbose reference standard by transferred method was contrasted with two new methods： HPLC - ELSD/DAD. Both of them used C18 column to separate Acarbose and the related substances by RP - HPLC. RESULTS The result of transferred determination was 98.9% ,the result of DAD method was 99.0% with RSD of 0.4%, and that of ELSD method was 98.6% with RSD of 1.2%. CONCLUSION The method is sensitive ,accurate and reliable. It can be used for quality control of working reference standard of Acarbose.