目的 对抗银屑病新药艾托莫德原料药中的7种有关物质Imp-A~Imp-G进行结构鉴定。方法 利用高效液相色谱-四级杆线性离子阱质谱联用法(HPLC-QTrap-MS)推测各有关物质的结构，高效液相色谱-四级杆飞行时间质谱联用法(HPLC-QTOF/MS)技术快速确证各结构的相对分子质量及分子组成。结果 获得了艾托莫德原料药中的7种有关物质Imp-A~Imp-G的相对分子质量及结构式。结论 方法快速、简便，为原料药的杂质解析提供了良好的思路，并为创新药物艾托莫德的有关物质研究及质量控制提供了有意义的实验数据和参考依据。
Abstract
OBJECTIVE To identify the related substances in aituomode bulk drug. METHODS HPLC-QTrap-MS and HPLC-QTOF-MS were used to determine seven kinds of related substances denoted by Imp-A to Imp-G. RESULTS The structures and molecular weights of the related substances in aituomode were identified. CONCLUSION The method is simple and accurate, providing a good idea for the identification of the related substances in bulk drugs. The experimental data are valuable to the determination of the related substances and quality control of aituomode.
关键词
艾托莫德 /
高效液相色谱-四级杆飞行时间质谱联用法 /
有关物质 /
生产工艺
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Key words
aituomode /
HPLC-QTOF/MS /
related substances /
production technologie
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中图分类号：
R917
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参考文献
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脚注
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基金
中央级公益性科研院所基本科研业务费专项基金资助项目(2015CX09)
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