摘要
鉴定头孢美唑钠系统适用性对照品。方法:以0.1%甲酸溶液-乙腈为流动相,结合正离子和负离子两种模式下检测的母离子及子离子谱,参考文献推测杂质的结构。结果:在液相条件下,检测到分离良好的8个明显的杂质,对其杂质进行结构解析。结论:建立的液质条件有效地分离了头孢美唑钠系统适用性对照品中各有关物质,为其质量控制提供参考。
The system suitability reference substance of cefmetazole sodium was elucidated. Methods： HPLC separation was carried out by a mobile phase consisting of 0.1% formic acid aqueous solution and pure acetonitrile. The parent ions and product ions were detected both in positive mode and negative mode. The structures of impuri- ties were assigned combined with literatures. Results： Eight impurities were detected under HPLC conditions and well-separated. Their structures were identified. Conclusions： Impurities in system suitability were effectively sepa- rated by LC-MS method. The results were useful for quality control.
作者
刘云飞
周浩
于佳
王凌波
张士博
王润德
金金
杨利红
LIU Yun-fei ZHOU Hao YU Jia WANG Ling-bo ZHANG Shi-bo WANG Run-de JIN Jin YANG Li-hong(Chiatai Tianqing Pharmaeeutieal Group Limited by Shares, Nanjing, 210023, China Heilongjiang Institute for Food and Drug Control, Harbin 150088,China)
出处
《化学工程师》
CAS
2017年第8期74-80,共7页
Chemical Engineer
基金
哈尔滨市应用技术研究与开发项目-科技创新人才(No.2015RQQYJ002)
黑龙江省自然科学基金项目(No.H201452)
关键词
头孢美唑钠
系统适用性对照品
结构解析
cefmetozole sodium
system suitability reference substance
structural analysis.
