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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

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【作者】 杨萍崔振辉

【Author】 YANG Ping and CUI Zhen-hui (Harbin Pharmaceutical Group,Harbin 150086)

【机构】 哈药集团制药总厂

【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。

【Abstract】 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.

  • 【文献出处】 黑龙江科学 ,Heilongjiang Science , 编辑部邮箱 ,2012年02期
  • 【分类号】R927.2
  • 【下载频次】37
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