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HPLC法测定兰索拉唑及其制剂的含量和有关物质
引用本文:高洁,朱永琴. HPLC法测定兰索拉唑及其制剂的含量和有关物质[J]. 河南师范大学学报(自然科学版), 2008, 36(4)
作者姓名:高洁  朱永琴
作者单位:1. 中央广播电视大学,北京,100031
2. 河南省食品药品检验所,郑州,450003
基金项目:国家自然科学基金 , 河南省教育厅自然科学研究计划项目
摘    要:用HPLC法测定兰索拉唑及其制剂的含量和有关物质.方法使用Dikma Diamonsil TM-C18色谱柱(4.6 mm×250 mm,5μm);甲醇-水-三乙胺-磷酸溶液(700∶300∶5∶1.5)(磷酸调pH值为7.3)流动相;检测波长:284 nm;流速:1.0 mL.min-1;柱温:30℃;进样量:20μL.兰索拉唑峰与其相邻杂质峰分离完全,兰索拉唑在14.92~124.32μg.mL-1(r=0.9995)浓度范围内线性关系良好.该法简便、准确、专属性好,可用于兰索拉唑及其制剂的含量和有关物质检查.

关 键 词:高效液相色谱  兰索拉唑  注射用兰索拉唑

HPLC Determination of Lansoprazole and Its Related Substances
GAO Jie,ZHU Yong-qin. HPLC Determination of Lansoprazole and Its Related Substances[J]. Journal of Henan Normal University(Natural Science), 2008, 36(4)
Authors:GAO Jie  ZHU Yong-qin
Abstract:The experiment exploits the HPLC method for the determination of lansoprazole and its related substances.The HPLC system consists of a Dikma DiamonsilTM-C18 column(4.6 mm×50 mm,5 μm) and a mixture of methanolwater-thiethylamine-phosphoric acid solution(700∶300∶5∶1.5)(adjust pH to 7.3 with phosphoric acid) as mobile phase.The flow rate is 1.0 mL·min-1 with detection wavelength at 284 nm and column temperature at 30 ℃.Lansoprazole could be completely separated from other impurities.The linear range of lansoprazole is 14.92~124.32 μg·ml-1(r=0.999 5).The method is simple,accurate and it is suitable for the determination of lansoprazole and its related substances.
Keywords:HPLC  lansoprazole  lansoprazole for injection
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