【摘要】 目的:建立气相色谱法测定威替米星原料药中有机残留溶剂的含量。方法:采用气相色谱法,色谱柱为HP5(5%苯基甲基硅酮)毛细管柱(30m×320μm×0.25μm),载气为氮气,以程序升温方式使乙醇、二氯甲烷、乙二醇二甲醚和二甲基甲酰胺达到了完全分离,检测器为氢火焰离子化检测器。结果:在该法采用的色谱条件下,测定4种溶剂线性关系、精密度、准确度、灵敏度均达到了预定的分析要求,在威替米星原料药中检出了乙醇。结论:本法能快速准确的对涉及的4种有机溶剂进行检测,可用于威替米星原料药质量控制中的有机残留溶剂检查。更多还原

【Abstract】 AIM: To establish a gas chromatography （GC） method used for determination of residue organic solvent in vertilmicin substance. METHODS: GC was used for determination of residue organic solvent; column:HP-5 capillary column（（30 m）×（320 um×）0.25 um）; carrying gas: N₂. Ethanol, dichloromethane, ethylene glycol dimethyl ether and N,N-dimethylformamide were separated completely through gradient temperature with flame ionization detector. RESULTS: The linearity, precision, accuracy and sensitivity of the four solvents under condition of this method were complied with the predefined analytical requirements. Ethanol was detected in vertilmicin substance. CONCLUSION: This method （GC） is rapid and accurate to determine the four solvents as the residue organic solvent in vertilmicin.更多还原