阿卡波糖有关物质的方法学研究  

Related Substances Study of Acarbose Raw Materials

作　　者：武晗燕[1] 周长明[1] 段艳 姚瑛[1] Hanyan WU;Changying ZHOU;Yan DUAN;Ying YAO(Beijing Institute of Drug Control,Beijing 102206)

机构地区：[1]北京市药品检验所中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《生命科学仪器》2019年第6期105-108,共4页Life Science Instruments

基　　金：中国药典委员会《中国药典》药品标准提高专项。

摘　　要：本文采用高效液相色谱法测定阿卡波糖原料中的有关物质。方法:采用高效液相色谱法,色谱柱为氨丙基硅烷键合硅胶色谱柱(150mm×4.6mm,3μm);流动相为磷酸盐缓冲液-乙腈(22:78);检测波长为210nm;流速为2.7ml/min。结果:通过改进实验条件,提高了杂质A与主成分的分离度;通过方法学试验,确定该方法的专属性、重现性均较好,可行性较高。The aim of this study to establish an high performance liquid chromatography(HPLC)method to determine the related substances in the acarbose raw materials.Method:Amino column(150 mm×4.6 mm,3μm)was adopted.The mobile phase was phosphate buffer-acetonitrile(22:78)at the flow rate of 2.7 ml/min.The detection wavelength was 210 nm.Results:By improving the experimental conditions,the separation degree between impurity A and main component was improved.The methodological test confirmed that the method has good specificity and reproducibility,and the feasibility is high.

关 键 词：高效液相色谱法 阿卡波糖原料 有关物质 

分 类 号：O657[理学—分析化学]