顶空气相色谱法测定注射用阿莫西林钠克拉维酸钾残留溶剂含量  

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

作　　者：杨萍[1] 崔振辉[1] 

机构地区：[1]哈药集团制药总厂,黑龙江哈尔滨150086

出　　处：《黑龙江科学》2012年第2期61-63,共3页Heilongjiang Science

摘　　要：测定注射用阿莫西林钠克拉维酸钾中甲醇、异丙醇、乙酸丁酯有机溶剂残留量。采用顶空气相色谱法,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℃。顶空瓶平衡温度80℃平衡时间30min。平均回收率:甲醇100.8%;异丙醇101.2%;乙酸丁酯100.5%。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。Using the headspace Gas-chromatography methods to measure the assay of residual solvent （Methanol, 2-Propanol, Butyl acetate） meanwhile in Amoxicillin Sodium and Claulanale Polassium 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 Methanol, 2-Propanol, Butyl 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.

关 键 词：顶空气相色谱法 残留溶剂 弹性石英毛细柱 

分 类 号：R917[医药卫生—药物分析学]