| LC-MS/MS法检测西维来司他原料药中的降解产物 |
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| 引用本文： | 张爱军,郭继芬,赵玲,赵毅民,王亚芹.LC-MS/MS法检测西维来司他原料药中的降解产物[J].中国新药杂志,2006,15(9):712-715. |
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| 作者姓名： | 张爱军 郭继芬 赵玲 赵毅民 王亚芹 |
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| 作者单位： | 1. 军事医学科学院毒物药物研究所,北京,100850
2. 北京百奥药业有限公司,北京,100101 |
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| 摘 要： | 目的：探讨应用液相色谱-串联质谱法（LC-MS/MS）检测西维来司他原料药中的降解产物.方法：以乙腈-水-甲酸（40：60：0.1）为流动相,待测物经Hypersil C18柱分离,电喷雾串联质谱在线检测,获得相关的色谱和质谱信息.结果：在所应用的条件下,西维来司他与其降解产物达到了很好分离,主成分和其降解产物峰的保留时间分别为18.46和3.36min,同时通过两者的质谱特征获得了降解产物的结构信息.结论：所建立的方法能快速、准确地分离鉴定西维来司他原料药中的降解产物,从而可以对其原料药进行质量控制.
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| 关 键 词： | 西维来司他 液相色谱-串联质谱法 降解产物 |
| 文章编号： | 1003-3734（2006）09-0712-04 |
| 收稿时间： | 2006-01-07 |
| 修稿时间： | 2006年1月7日 |
Identification of degradation products in raw materials of sivelestat by LC-MS/MS |
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| ZHANG Ai-jun,GUO Ji-fen,ZHAO Ling,ZHAO Yi-min,WANG Ya-qin.Identification of degradation products in raw materials of sivelestat by LC-MS/MS[J].Chinese Journal of New Drugs,2006,15(9):712-715. |
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| Authors: | ZHANG Ai-jun GUO Ji-fen ZHAO Ling ZHAO Yi-min WANG Ya-qin |
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| Abstract: | Objective:To establish a liquid chromatography-tandem mass spectrometry(LC-MS/ MS)method for the identification of the degradation products in raw materials of sivelestat.Methods: The LC was conducted in a system containing a hypersil C_(18)column,an eluate of acetonitrile:water:for- mate(40:60:0.1).The analyte was detected by an eletrospray ionization tandem spectrometry in nega- tive ion mode.Results:Sivelestat was completely separated from the degradation products with the reten- tion time of 18.46 min versus 3.36 min.The structures of the degradation products were elucidated using the subsequent MS/MS spectra of sivelestat arid its degradation products.Conclusion:The sensitive and specific LC-MS/MS method can be used for the quality control of sivelestat. |
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| Keywords: | sivelestat liquid chromatography-tandem mass spectrometry degradation product |
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