顶空气相色谱法测定舒萨林中残留溶剂含量

Determination of the Residual Solvent Content in Amoxicillin Sodium and Sulbactam Sodium for Injection by Headspace Gas-chromatography Methods

目的:用顶空气相色谱法测定舒萨林中乙醇、异丙醇、乙酸乙酯有机溶剂残留量。方法:利用顶空气相色谱法,在大口径弹性石英毛细柱上进行各组分分离,各组分间的分离度均符合要求。柱温:80℃;进样口温度:200℃;检测器温度250℃。顶空瓶平衡溫度80℃平衡时间30分钟。结果:平均回收率:乙醇100.8%异丙醇101.2%乙酸乙酯100.5%。结论:该方法利用顶空气相色谱法克服了各组分分离度达不到要求的缺点,重现性好,精度高。

Objective：Using the headspace Gas-chromatography methods to measure the assay of residual solvent（Ethanol,2-Propanol,Ethyl acetate）meanwhile in Amoxicillin Sodium and Sulbactam Sodium for Injection.Methods：auto-injection using external standard headspace method,which make the component can be separated at the neutral polarity elastic capillany column,the result is good.The oven temperature was set at 80℃,with injector at 200℃ and FID temperature at 250℃.The equilibrium temperature of headspace was set at 80℃,with time at 30 minutes.Results：the average recovery was at 100.8%,101.2% and 100.5% for Ethanol,2-Propanol,Ethyl acetate.Conclusion：using the method can obtain a good repeatability.Conclusion：headspace Gas-chwmatography acid of Azithrony cin Lactobionate is entirely separated by this method and obtain highly precision.