阿戈美拉汀原料及其胶囊有关物质检查方法的研究  

Determination of Related Substances in Agomelatine and Its Capsules

作　　者：邹巧根[1] 胡紫艳[2] 韦萍[1] 

机构地区：[1]南京工业大学制药与生命科学学院,江苏南京210009 [2]江苏省药物研究所有限公司,江苏南京210009

出　　处：《南京晓庄学院学报》2011年第6期45-49,共5页Journal of Nanjing Xiaozhuang University

基　　金：国家重点基础研究发展计划(No.2009CB724700)

摘　　要：目的:建立HPLC法检查阿戈美拉汀中的主要有关物质测定方法.方法:采用Dikma-C18色谱柱(150 mm×4.6 mm,5μm);以0.1%磷酸溶液(三乙胺调节pH值至3.0)-乙腈为流动相,采用梯度洗脱;流速为1 mL·min-1;检测波长为231 nm.结果:HPLC法能有效检出阿戈美拉汀及其胶囊中的主要杂质,最低检出限为5.17×10-4 ng.结论:该方法灵敏度高、专属性好,适用于阿戈美拉汀及其胶囊的有关物质检查.The present study is to establish an HPLC method for related substances test in agomelatlne anu its capsules. In the study, Dikma-C18 column （ 150 mm × 4.6 mm, 5 μm） was used, with 0.1% H3PO4 （pH 3.0, adjusted by triethanolamine）-acetonitrile as a mobile phase with gradient elution at a flow rate of 1.0 mL/min, and the detection wavelength was 231 nm. Results showed that the main related substances in agomelatine were effectively determined by HPLC, with the limit of detection at 5.17 × 10-4 ng. It is concluded that the method proposed for determination of the related substances in agomelatine and its capsules is sensitive and specific.

关 键 词：阿戈美拉汀 高效液相色谱法 有关物质 

分 类 号：R927[医药卫生—药学]