| 液质联用快速确定尼群地平原料药中的杂质 |
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| 引用本文： | 朱培曦,陈娟娟,李会林,周明昊.液质联用快速确定尼群地平原料药中的杂质[J].药物分析杂志,2012(1):88-91. |
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| 作者姓名： | 朱培曦 陈娟娟 李会林 周明昊 |
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| 作者单位： | 浙江省食品药品检验所;宁波大学应用海洋生物技术教育部重点实验室 |
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| 摘 要： | 目的:利用液质联用技术对尼群地平原料药中的2个杂质进行在线的质谱分析。方法:采用C18(250 mm×4.6 mm,5μm)色谱柱,流动相为甲醇-水(70︰30),流速为1.0 mL.min-1;Agilent 6320质谱仪,离子源为ESI,质量分析器为离子阱,检测模式为正离子。结果:直接推断出了2个杂质可能的化学结构。结论:检测结果对于尼群地平原料药的杂质分析、质量控制和合成工艺的改进具有重要作用。
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| 关 键 词： | 高效液相色谱 质谱 尼群地平 原料药 杂质结构鉴定 有关物质分析 |
Characterization of impurities in nitrendipine bulk drug by liquid chromatography/ion trap mass spectrometry |
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| ZHU Pei-xi,CHEN Juan-juan,LI Hui-lin,ZHOU Ming-hao.Characterization of impurities in nitrendipine bulk drug by liquid chromatography/ion trap mass spectrometry[J].Chinese Journal of Pharmaceutical Analysis,2012(1):88-91. |
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| Authors: | ZHU Pei-xi CHEN Juan-juan LI Hui-lin ZHOU Ming-hao |
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| Institution: | 1(1.Zhejiang Institute for Food and Drug Control,Hangzhou 310004,China; 2.Key Laboratory of Applied Marine Biotechnology,Ningbo University,Ministry of Education,Ningbo 315211,China) |
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| Abstract: | Objective:To establish the method for the detection of impurities in nitrendipine bulk drug by means of high-performance liquid chromatography coupled with tandem mass spectrometry(HPLC-MSn).Methods: The identification of nitrendipine was carried out.Separation was performed on C18 column(250 mm×4.6 mm,5 μm),the mobile phase consisted of methanol-water(70 ︰ 30)and the flow rate was 1.0 mL·min-1;An Agilent 6320 ion trap mass spectrometer with an ESI source was used for LC-MSn analysis,utilizing the positive detection mode.Results: The chemical structures of two impurities were elucidated.Conclusion: The results of determination offer the scientific data for studying the origin of the impurities of nitrendipine and improving its quality. |
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| Keywords: | HPLC MS nitrendipine crude drug impurity structure identification related substance analysis |
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