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中文摘要：
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．
英文摘要：
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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