LC-MS/MS法检测西维来司他原料药中的降解产物  

Identification of degradation products in raw materials of sivelestat by LC-MS/MS

作　　者：张爱军[1] 郭继芬[1] 赵玲[1] 赵毅民[1] 王亚芹[2] 

机构地区：[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

出　　处：《中国新药杂志》2006年第9期712-715,共4页Chinese Journal of New Drugs

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 C_(18)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,西维求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3．36 min,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。、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 C18 column, an eluate of acetonitrile： water： formate （40： 60： 0. 1 ）. The analyte was detected by an eletrospray ionization tandem spectrometry in negative ion mode. Results： Sivelestat was completely separated from the degradation products with the retention 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 and its degradation products. Conclusion： The sensitive and specific LC-MS/MS method can be used for the quality control of sivelestat.

关 键 词：西维来司他 液相色谱-串联质谱法 降解产物 

分 类 号：R917.4[医药卫生—药物分析学] R974[医药卫生—药学]