| 阿戈美拉汀原料及其胶囊有关物质检查方法的研究 |
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| 引用本文： | 邹巧根,胡紫艳,韦萍.阿戈美拉汀原料及其胶囊有关物质检查方法的研究[J].南京晓庄学院学报,2011(6):45-49. |
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| 作者姓名： | 邹巧根 胡紫艳 韦萍 |
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| 作者单位： | 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 |
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| 基金项目： | 国家重点基础研究发展计划(No.2009CB724700) |
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| 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（150mm×4．6mm，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1mL·min-1；检测波长为231nm．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5．17×10-4ng．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．
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| 关 键 词： | 阿戈美拉汀 高效液相色谱法 有关物质 |
Determination of Related Substances in Agomelatine and Its Capsules |
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| ZOU Qiao-gen,HU Zi-yan,WEI Ping.Determination of Related Substances in Agomelatine and Its Capsules[J].Journal of Nanjing Xiaozhuang College,2011(6):45-49. |
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| Authors: | ZOU Qiao-gen HU Zi-yan WEI Ping |
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| Institution: | ZOU Qiao-gen1,HU Zi-yan2,WEI Ping1(1.Dept.of Biology and Pharmacy Engineering,Nanjing University of Technology,Nanjing 210009,Jiangsu,2.Jiangsu Provincial Institute of Pharmacy,Jiangsu) |
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| Abstract: | 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. |
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| Keywords: | agomelatine HPLC related substances |
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