LC-MS/MS法检查注射用氟氯西林钠中的有关物质

Determination of Related Substances in Flucloxacillin Sodium for Injection by LC-MS/MS

目的:检查注射用氟氯西林钠中的有关物质。方法:采用液相色谱-质谱/质谱技术。液相条件:色谱柱为HypersilODS,柱温为20℃,流动相为乙腈-0.5mmol/L醋酸铵溶液(pH=5.0)(30:70),流速为1.0ml/min;质谱条件:ESI离子源;正离子模式,Q1全扫描,Q2扫描,多离子反应监测(MRM)模式,扫描范围100～1000amu。结果:从注射用氟氯西林钠中鉴别出5种有关物质,并初步确定成分及主要离子碎片结构。结论:本法能够快捷、方便地检查出注射用氟氯西林钠中的有关物质。

OBJECTIVE：To determine the related substances in Flucloxacillin sodium for injection.METHODS：LC-MS/MS was used.The determination was performed on Hypersil ODS column with mobile phase of acetonitrile-0.5 mmol/L ammonium acetic（pH=5.0）（30：70）at the flow rate of 1.0 ml/min,and the column temperature was 20 ℃.MS parameter：ESI ion source,positive monitoring,Q1 full scan mode,Q2 scan mode,MRM,scanning scope of 100-1 000 amu.RESULTS：5 related substances were identified in Flucloxacillin sodium for injection,and the components and main fragment structure were determined primarily.CONCLUSIONS：The method is rapid and convenient for the determination of related substances in Flucloxacillin sodium for injection.