HPLC测定注射用兰索拉唑中兰索拉唑的含量和有关物质  

Determination of Lansoprazole and Its Related Substance in Lansoprazole for Injection by HPLC

作　　者：杨艳[1] 谢俊霞[1] 李冰[1] 孙英华[1] 方金玲[1] 刘艳[1] 何仲贵[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中国药学杂志》2006年第7期538-540,共3页Chinese Pharmaceutical Journal

摘　　要：目的采用高效液相色谱法建立注射用兰索拉唑有关物质检查及其含量测定方法。方法Diamonsil—-C18柱（4-6mm×200mm，5μm），以甲醇-水-三乙胺-磷酸（640：360：5：1．5，pH为7．3）为流动相，检测波长为284nm结果制剂中辅料对主药测定无干扰．兰索拉唑与有关物质完全分离．在10．0-400．0mg·L^-1内峰面积与球度呈良好的线性关系。精密度（RSD=0．13％）良好。平均回收率为99．6％．结论本方法简便，迅速，准确，专属性强.OBJECTIVE To establish a HPLC method for determing the content of lansoprazole and screening its related substance in lanseprazole for injection.METHODS A Diamonsil - C18 column （4.6 mm× 200 mm, 5μm） was used. The mobile phase was methanol-watertriethylamin-phosphoric acid （640：360：5：1.5,pH 7.3）.The determination wavelength was 284 nm.RESULTS The excipients did not interfere with the determination of lansoprazole. Lansoprazole and its related substance were absolutely separated. The linear range of lansoprazole was 10.0 - 400.0 mg· L^-1. The precision of the method （RSD = 0.13% ）was good. The average recovery was 99.6%. CONCLUSION The method is simple, speedy, accurate and specific.

关 键 词：高效液相色谱法 注射用兰索拉唑 含量测定 有关物质 

分 类 号：R917[医药卫生—药物分析学]