GC法测定法罗培南钠有机溶剂残留量

Detection of Residual Solvents in Faropenem Sodium by GC

目的:建立法罗培南钠原料药中有机溶剂残留量测定方法。方法:采用气相色谱法测定,色谱柱为HP-5弹性石英毛细管柱(30 m×0.53 mm,1.5 μm,以5％苯基-95％甲基聚硅氧烷为固定液),进样口温度:200℃,氢火焰离子化检测器(FID),检测器温度:250℃;柱温:程序升温,初始温度35℃,保持5 min,以每分钟10℃的升温速率升温至120℃,保持2 min,再以每分钟35℃的升温速率升温至250 ℃,保持5 min,载气:氮气,流速:2 mL/min,分流比:1:1,尾吹流速:30mL/min,以N-甲基吡咯烷酮为溶剂。结果:待测物均能得到很好的分离,峰面积与浓度呈良好的线性关系,精密度良好。结论:该法可用于法罗培南钠原料药中有机溶剂残留量的检测。

Objective: To establish a method for detection of the residual solvents in Faropenem sodium. Methods: The residual solvents in Faropenem sodium were determined by GC with HP-5 capillary column (30 m×0.53 mm, 1.5 μm) , FID detector and using nitrogen as carrier gas. The injector temperature was 200 ℃ and the detector temperature was 250 ℃. The column temperature was raised by program, the initial temperature was 35 ℃, maintained for 5 min, raised to 120 ℃ with a rate of 10 ℃/min, maintained for 2 min, then raised to 250 ℃ with a rate of 35 ℃/min, and maintained for 5 min. The flow rate of nitrogen was 2 mL/min. The split ratio was 1:1. The make-up gas rate was 30 mL/min. Results: The solvents can be completely separated and the calibration curves of each solvent showed good linear relationship within a certain range. Conclusions: The method is accurate and reliable. It can be applied in detection of residual solvents in Faropenem sodium.