顶空气相色谱法测定注射用哌拉西林钠舒巴坦钠(4:1)残留溶剂含量  

Determination of the Residual Solvent Content in Piperacillin Sodium and Sulbactam Sodium for Injection(4:1) by Headspace Gas-chromatography Methods

作　　者：王晶[1] 尹丽红[1] 

机构地区：[1]哈药集团制药总厂,黑龙江哈尔滨150086

出　　处：《黑龙江医药》2010年第5期688-690,共3页Heilongjiang Medicine journal

摘　　要：目的:用顶空气相色谱法测定注射用哌拉西林钠舒巴坦钠(4:1)中丙酮、二氯甲烷有机溶剂残留量。方法:利用顶空自动进样装置,外标法,在大口径弹性石英毛细柱上进行各组分分离,克服了进样量不准确的缺点,各组分间的分离度均符合要求。柱温:90℃;进样口温度:200℃;检测器温度300℃。顶空瓶平衡溫度80℃,平衡时间30分钟。结果:平均回收率:丙酮:100.6%二氯甲烷99.8%。结论:该方法利用顶空气相色谱法克服了进样量不准确,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 method to measure the assay of residual solvent（acetone,methylene chloride）meanwhile in Piperacillin Sodium and Sulbactam Sodium for Injection（4：1）.Methods：auto-injection using external standard headspace method,which make the component can be separated at the wide polarity elastic capillany column,the result is good.It overcomes the weakness of injecting measure。It can be entirely separated by this method.The oven temperature was set at 90℃,with injector at 200℃ and FID temperature at 300℃.The equilibrium temperature of headspace was set at 80℃,with time at 30 minutes.Results：the average recovery was at 100.6 % and 99.8% for acetone and methylene chloride.Conclusion：using the method can obtain a good repeatability.headspace Gas-chromatography of Piperacillin Sodium and Sulbactam Sodium for Injection（4：1）overcome the weakness of injecting measure.is entirely separated by this method and obtain highly precision.makethe quantify accurate.

关 键 词：顶空气相色谱法 残留溶剂 弹性石英毛细柱 外标法 

分 类 号：R927.1[医药卫生—药学]