第 46 卷第 5 期 Vol. 46 No. 5 2016 年 10 月 Oct 2016

所属栏目：分析与测试 雷贝拉唑钠肠溶胶囊（微丸型）的HPLC分析

谢 斌1，2，3，4，周 建1，朱小庆1，冯伟霞1，张 武1，黄俊鹏1，关 东1，陈新民1，2，3，4 （1. 珠海润都制药股份有限公司，广东 珠海 519041；2. 珠海润都制药股份有限公司博士后科研工作站，广东 珠海 519041；3. 广东省工程技术研究中心，广东 珠海 519041；4. 珠海市微丸制剂技术研究中心，广东 珠海 519041）

摘　要：建立HPLC法测定雷贝拉唑钠肠溶胶囊（微丸型）的有关物质。 采用Agilent ZORBAX（4.6 mm×250 mm，5 μm）色谱柱，流动相采用0.015 mol／L磷酸氢二钠溶液（用磷酸调节pH值至6.0）-乙腈（v∶v=65∶35），等度洗脱，流速为1.0 mL／min，柱温：30℃，检测波长为290 nm。该色谱条件下，主成份与已知杂质分离度良好。雷贝拉唑钠的检测限为3.3 μg／mL，定量限为10 μg／mL，是供试品进样量的0.33%和1.00%，满足杂质检测和控制。通过稳定性的考察，供试品溶液不稳定，需要现用现配。该方法简单、快速、准确，可用于雷贝拉唑钠肠溶胶囊（微丸型）的质量控制。

关键词：高效液相色谱法；雷贝拉唑钠肠溶胶囊（微丸型）；有关物质

中图分类号：Q657.7+2　　文献标识码：A　　文章编号：1009-9212（2016）05-0063-04

Determination of Rabeprazole Sodium Enteric-coated Capsules (micro pill)

XIE Bin1,2,3,4, ZHOU Jian1, ZHU Xiao-qing1, FENG Wei-xia1, ZHANG Wu1, HUANG Jun-peng1, GUAN Dong1, CHEN Xin-min1,2,3,4 (1. Zhuhai Rundu Pharmaceutical Co., Ltd., Zhuhai 519041, China; 2. Postdoctoral Science Research Workstation of Zhuhai Rundu Pharmaceutical Co., Ltd., Zhuhai 519041, China; 3. Guangdong Engineering and Technology Research Center, Zhuhai 519041, China; 4. Zhuhai Technology Research Center for Pellets Formulation, Zhuhai 519041, China)

Abstract：A HPLC method for the determination of related substances in rabeprazole sodium was established.The determination was performed on an Agilent ZORBAX(4.6 mm×250 mm, 5 μm) column. The mobile phase consisted of 0.015 mol/L Sodium phosphate dibasic (adjusted pH value 6 with phosphoric acid)-acetonitrile(65:35). Other conditions for the separation were including isocratic elution, a flow rate of 1 mL/min, column temperature of 30℃, detection wavelength of 290 nm. Ralated substances were completely separated from the main constituent. The detection limit for rabeprazole was 3.3 μg/mL and the quantification limit was 10 μg/mL, which were 0.33% and 1.00% of test sample,respectively. The solution is not stable, it needed to be used at present. The method simple, rapid and accurate, and can be used to control the quality of rabeprazole sodium enteric-coated pellets.

Key words：HPLC; rabeprazole sodium enteric-coated capsules (micro pill); ralated substances

作者简介：谢 斌（1975-），男，安徽宿州人，副研究员，博士，研究方向：新药研究与开发（E-mail：42276143 @qq.com）。

收稿日期： 2016-07-2