奥硝唑有关物质的液相色谱-电喷雾离子化-质谱联用分析

目的：对奥硝唑有关物质进行分析。方法：采用液相色谱-电喷雾离子化．质谱联用分析技术，Luna C18柱（4．6mm×250mm，5μm）；以pH3．5甲酸水溶液：乙腈（80：20）为流动相；DAD检测器检测波长为318nm；柱温25℃；流速1mL·min^-1，柱后分流；进样量20μL。质谱离子源为ESI，雾化气压力30psi，干燥气流量8L／min，干燥温度350℃，质谱扫描质量范围50～1200。采用全扫描一级质谱（full scan）和选择离子全扫描二级质谱（full scan MS／MS）两种方式同时测定。结果：分析了奥硝唑的两个主要降解产物的结构。结论：奥硝唑制剂的质量控制应从制剂工艺控制上体现。

Analysis of Ornidazole's Related Substances by LC-ESI-MS

Objective： To analyze the Ornidazole＇s related substances. Method： Detections were performed by an Agilent 1100 ion trap mass spectrometer. Chromatographic separation was carried out at 25 ℃ using an Luna Cls analytical column（4.6 mm ×250 mm, 5 μm）. The mobile phase consisted of pH 3.2 formic acid solution and acetonitrile. The flow rate was 1 mL · min ^-1, split after the column. The mass spectrometry detector（MSD） was equipped with an ESI source, mass scan range was 50 - 1 200 m/z. Samples were analyzed in two modes ： MS and MS/MS full scan modes. Results： Two main degradation products of ornidazole were characterized. Conclusion： The produce procedure control of the products of ornidazole should be the beginning of the quality control.