GC测定注射用阿莫西林钠中残留的有机溶剂

目的建立注射用阿莫西林钠有机溶剂残留量的测定方法。方法采用顶空进样毛细管气相色谱法,色谱柱为DB-624毛细管柱（30m×0.25mm,1.4μm）,柱温：40℃,顶空温度85℃,平衡时间：30min,进样口温度：200℃,FID检测器温度：250℃,以正丙醇为内标,高纯氮气为载气,测定了注射用阿莫西林钠中7种有机溶剂的残留量。结果各有机溶剂均能得到有效分离,在所考察的浓度范围内线性关系良好,r为0.9990～0.9998,平均回收率为91.3%～105.7%。结论本方法灵敏、简便、结果准确,可用于注射用阿莫西林钠中残留溶剂的检测。

Determination of Residual Organic Solvents in Amoxicillin Sodium for Injection by GC

OBJECTIVE To establish a method for determination of residual organic solvents in amoxicillin sodium for injection.METHODS A DB-624 capillary column（30 m×0.25 mm,1.4 μm） was used at 40 ℃,the headspace temperature was 85 ℃ and kept for 30 minutes,the temperature of inlets and FID detector were 200 ℃ and 250 ℃,propanol as internal standard,high purity nitrogen as the carry gas.RESULTS Seven residual organic solvents were completely separated and there were good linearies（r=0.999 0-0.999 8）.The average recovery rate was in the range of 91.3%-105.7%.CONCLUSION The method proved to be sensitive,simple and accurate,and can be used for determination of residual organic solvents in amoxicillin sodium for injection.