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目的:建立阿莫西林钠原料药中有机溶剂残留量的分离测定方法。方法:采用顶空气相色谱法,载气为氮气,FID检测器,色谱柱为HP-1毛细管柱,程序升温,外标法测定了阿莫西林钠中乙醇、异丙醇、二氯甲烷、二乙胺、三乙胺的残留量。结果:5种有机溶剂完全分离,在所考察的浓度范围内具有良好的线性关系,r为0.999 0～0.999 5,平均回收率为92.9%～105.7%,RSD均小于10%,最低检测限为0.004～0.05μg·ml~(-1)。结论:方法快速、灵敏,适用于阿莫西林钠中有机溶剂残留量的测定。
Objective: To establish a method for the separation and determination of organic solvent residues in amoxicillin sodium raw material. Methods: HPLC, carrier gas of nitrogen, FID detector, column was HP-1 capillary column, temperature programmed, amoxicillin sodium in the determination of ethanol, isopropanol, methylene chloride, Diethylamine, triethylamine residues. Results: The five organic solvents were completely separated and had a good linear relationship in the concentration range studied. The average recoveries were from 0.999 0 to 0.999 5 and the average recoveries were 92.9% -105.7% with RSDs less than 10%. The lowest detection limit was 0.004 ~ 0.05μg · ml ~ (-1). Conclusion: The method is rapid and sensitive and suitable for the determination of residual organic solvents in amoxicillin sodium.