富马酸依美斯汀及其有关物质的HPLC法测定  

Determination of Emedastine Difumarate and Its Related Substances by HPLC

作　　者：周一萌[1] 周斌[1] 

机构地区：[1]中国医药工业研究总院上海医药工业研究院,上海201203

出　　处：《中国医药工业杂志》2016年第1期64-66,共3页Chinese Journal of Pharmaceuticals

摘　　要：建立了高效液相色谱法测定富马酸依美斯汀及其有关物质。使用Zorbax Extend-C18色谱柱,流动相为0.5%三乙胺溶液（用磷酸调至p H 7.6）∶甲醇∶乙腈（40∶42∶18）,检测波长284 nm。富马酸依美斯汀与有关物质的分离度良好。富马酸依美斯汀在0.05-1.0 mg/ml范围内线性关系良好,平均回收率为100.3%,RSD为0.12%。An HPLC method was established for the determination of emedastine difumarate and its related substances. A Zorbax Extend-Cx8 column was used with the mobile phase of 0.5 % triethylamine solution （adjusted to pH 7.6 with phosphoric acid） ： methanol ： acetonitrile （40 ： 42 ： 18） at the detection wavelength of 284 nm. Emedastine difumarate and its related substances were separated successfully. It was linear in the concentration range of 0.05- 1.0 mg/ml for emedastine difumarate. The average recovery was 100.3 %, with RSD of 0.12 %.

关 键 词：富马酸依美斯汀 有关物质 高效液相色谱 测定 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]