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 em-ployed. 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 at 20. 01 min and held until 30 min torecondition the column. The flow rate was 1 mL/min. Under this con-dition,each specified impurity and main components can be separated from each other,and the blank sol-vent 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. 9971;The proposed method is validated by methodology,showing that it is sensitive, accurate and suitable for the monitoring of organic impurities in Rabeprazole sulfide.%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 mL/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0.9971;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.
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