顶空气相色谱法测定注射用氨苄西林钠舒巴坦钠中残留溶剂  

Determination of the Residual Solvent Content in Ampicillin Sidium and Sulbactam Sodium for Injection by Headspace Gas-chromatography method

作　　者：张红梅[1] 

机构地区：[1]哈药集团制药总厂,哈尔滨150086

出　　处：《黑龙江医药》2009年第3期255-257,共3页Heilongjiang Medicine journal

摘　　要：目的:建立一种气相色谱法同时测定注射用氨苄西林钠舒巴坦钠中有机溶剂乙醛、乙醇、异丙醇、异丁醛含量的方法。方法:采用外标法顶空自动进样,在非极性弹性毛细管柱上进行分离,效果良好。结果:方法重现性好,定量准确,便于操作。结论:平均回收率乙醛99.3%-102.5%;乙醇100.0%-102.5%;异丙醇99.2%-102.3%;异丁醛100.3%-102.0%。变异系数乙醛2.2%;乙醇2.2%;异丙醇1.5%;异丁醛1.9%。Objective： Using the headspace Gas-chromatography methods to determine the assay of residual solvent （acetone, ethylene chloride, methanol and ethyl acetate） meanwhile in Ampicillin Sodium and Sulbactam Sodium for Injection. Methods： auto-injection using external standard headspace method, which make the component can be separated at the nonpolar elastic capillary column, the result is good. Results：using the method can obtain a good repeatability, make the quantify accurate and make it is easy to operate. Conclusion：the average recovery percentage： Acetaldehyde 98.3% -102.5%;Ethanol 100.0%-102.5%; 2-Propanol 99.2%-102.3%;2-Methylpropanal 100.3%-102.0%.Coefficient of variation： Acetaldehyde 2.2%; Ethanol 2.2%,;2-Propanol 1.5% and 2-Methylpropanal 1.9% .

关 键 词：顶空气相色谱法 注射用氨苄西林钠舒巴坦钠 残留溶剂 乙醛 乙醇 异丙醇 异丁醛 

分 类 号：R927.2[医药卫生—药学]