UPLC-Q-TOF-MS分析头孢美唑钠中有关物质

目的 建立UPLC-Q-TOF-MS分析头孢美唑钠原料中有关物质及其可能结构的方法。方法 应用超高效液相色谱-串联四极杆飞行时间质谱(UPLC-Q-TOF-MS)对头孢美唑钠原料中有关物质进行分析。采用Agilent XDB-C18 RRHD色谱柱(2.1mm×100mm, 1.8μm)，以乙腈-0.1%甲酸水(13:87)为流动相进行等度洗脱，流速为0.15mL/min，检测波长254nm，柱温40℃。结果 在原料药中共检出并推断出12种有关物质的化学结构，并解析了其裂解规律。结论 该方法快速、可靠、高效，适用于头孢美唑钠原料中有关物质的检查和结构解析，可为其质量控制和工艺优化提供参考。

Characterization of related substances in cefmetazole sodium by UPLC-Q-TOF-MS

Abstract Objective A UPLC-Q-TOF-MS method was established for the analysis and structure elucidation of related substances in cefmetazole sodium bulk materials. Methods The analysis was performed on an Agilent XDB-C18 RRHD (2.1mm×100mm, 1.8μm) column with acetonitrile and 0.1% formic acid water (13:87) as the mobile phase at a flow rate of 0.15mL/min. The detection wavelength was set at 254nm. The column temperature was set at 40℃. Results A total of 12 related substances in cefmetazole sodium bulk materials were identified, and theirfragmentation regularities were analyzed. Conclusion The method was accurate, reliable, and efficient, and was suitable for the analysis and structure elucidation of related substances in cefmetazole sodium bulk materials, and could provide a reference for its quality control and process optimization.