采用高效液相色谱-质谱联用技术鉴定喹硫平原料药中一种未知痕量杂质
Identification of an unknown trace-level impurity in bulk drug of Seroquel by high-performance liquid chromatography combined with mass spectrometry.
作者信息
Xu Hui, Wang Danhua, Sun Cuirong, Pan Yuanjiang, Zhou Minghua
机构信息
Department of Chemistry, Zhejiang University, Hangzhou 310027, China.
出版信息
J Pharm Biomed Anal. 2007 Jun 28;44(2):414-20. doi: 10.1016/j.jpba.2007.03.002. Epub 2007 Mar 7.
An impurity was detected in bulk drug Seroquel at about 0.4% level by the reversed-phase high-performance liquid chromatography with UV detection. The accurate mass of impurity was measured by FTICR equipped with electrospray ionization interface, and the structure of impurity was characterized on the basis of the on-line multi-stage mass spectrometric evidences. The proposed structure was further confirmed by multi-stage mass spectrometry of Seroquel and four related compounds.
通过带有紫外检测的反相高效液相色谱法，在原料药喹硫平中检测到一种含量约为0.4%的杂质。使用配备电喷雾电离接口的傅里叶变换离子回旋共振质谱仪测定了该杂质的精确质量，并基于在线多级质谱证据对杂质结构进行了表征。喹硫平和四种相关化合物的多级质谱进一步证实了所提出的结构。
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