HPLC法测定雷贝拉唑硫醚中的有机杂质  

Determination of the organic impurities in Rabeprazole sulfide by HPLC method

作　　者：王成[1] 谭淑珍[1] 姚倩 李蒲江 华坤鹏 

机构地区：[1]长沙理工大学化学与生物工程学院,湖南长沙410114 [2]湖南如虹制药有限公司,湖南岳阳414300

出　　处：《应用化工》2017年第9期1846-1848,1858,共4页Applied Chemical Industry

基　　金：湖南省教育厅资助科研项目(14A012)

摘　　要：开发了一种测定雷贝拉唑硫醚中5个杂质含量的HPLC方法,采用YMC Triart C18柱,柱温25℃;使用DAD检测器,检测波长269 nm;流动相由水(A)-乙腈(B)进行梯度洗脱(0~5 min,80%A→50%A;5~20 min,50%A;20~20.01 min,50%A→80%A;20.01~30 min,80%A),流速1 m L/min。在此条件下,主峰和各已知杂质之间能够彼此分离,空白溶剂不干扰杂质的测定,各已知杂质的平均回收率均在93.8%~102.3%范围内,RSD 1.7%~3.8%,各已知杂质的峰面积与浓度线性关系良好,相关系数R均大于0.997 1;方法学验证表明,该方法灵敏、准确,可用于雷贝拉唑硫醚中有机杂质的监控。A novel HPLC method was developed for simultaneous determination of five organic impurities in Rabeprazole sulfide. A YMC Triart C18 column at 25 ℃ and a DAD detector at 269 nm were employed. The mobile phase consisted of water( A) and acetonitrile( B). The proportion of A in the mobile phase was 80 at the start of each run,ramped to 50 at 5 min and held until 20 min,then returned to 80 at20. 01 min and held until 30 min torecondition the column. The flow rate was 1 m L/min. Under this condition,each specified impurity and main components can be separated from each other,and the blank solvent doesn't interfere with the test of each impurity. The average recoveries of each specified impurity are all in the range of 93. 8% ~ 102. 3%,with RSDs from 1. 7% ~ 3. 8%. The peak areas of each impurity versus its concentrations over the investigated range have good linearity,and the correlation coefficients R are all more than 0. 997 1;The proposed method is validated by methodology,showing that it is sensitive,accurate and suitable for the monitoring of organic impurities in Rabeprazole sulfide.

关 键 词：雷贝拉唑硫醚 有机杂质 高效液相色谱法 方法验证 

分 类 号：TQ460.72[医药卫生—药物分析学] TQ227.2[化学工程—制药化工]