UPLC/TOF MS用于头孢美唑钠系统适用性对照品的结构解析

Structural analysis of system suitability reference substance of cefmetazole sodium by UPLC/TOF MS

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.