毛细管气相色谱法测定氨曲南中4种有机溶剂残留量

 目的建立氨曲南中4种有机溶剂残留量的分离测定方法。方法采用直接进样毛细管气相色谱法,色谱柱为HP-FAPP毛细管柱,载气为氮气,FID检测器,二甲亚砜为溶解介质,检测了氨曲南原料药中甲醇、乙醇、丙酮、N,N-二甲基甲酰胺的残留量。结果4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,r为0.999 5～0.999 8,甲醇、乙醇、丙酮、N,N-二甲基甲酰胺的检测限分别为0.213,0.112,0.112,1.232μg·L^-1,精密度RSD均小于5%,平均回收率为102.25%～106.56%。结论本实验建立的方法简便灵敏,结果准确可靠,适用于氨曲南中有机溶剂残留量的检测。

Determination of Residual Solvents in Aztreonam by Capillary Gas Chromatography

OBJECTIVE To establish a method for the determination of four residual solvents in aztreonam.METHODS The residual solvents including methanol,ethanol,acetone,N,N-dimethylformamide(DMF) were quantitatively determined by capillary GC on HP-FAPP column.Dimethyl sulfoxide was solvent media,nitrogen was the carrier gas.RESULTS Four residual solvents were completely separated.A good linearity(r=0.999 5～0.999 8)was obtained.The detection limits of methanol,ethanol,acetone and DMF were 0.213,0.112,0.112,1.232 μg·L^-1;the RSDs of precision were less than 5%;the average recovery rates of the preparation were in the range of(102.25%～106.56%).CONCLUSION The method is simple,sensitive,accurate and can be used for the quality control of aztreonam.