GC测定注射用阿莫西林钠中残留的有机溶剂

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

摘要: 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(30 m×0.25 mm，1.4 μm)，柱温：40 ℃，顶空温度85 ℃，平衡时间：30 min，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0.999 0~0.999 8，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。

Abstract: 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.