浩瀚色谱（山东）应用技术开发有限公司建立了药包材产品中环氧乙烷残留量的顶空气相色谱分析方法。采用顶空气相色谱法,以Chromosorb 101  HP 60～80色谱柱为分离柱,检测器为氢火焰离子化检测器(FID)。结果表明环氧乙烷能与其他色谱峰很好的分离,分离度大于2.0,环氧乙烷在0.3982~12.7424μg/mL的浓度范围内线性关系良好(R²=1.0),方法的检出限(LOD)为0.025μg/mL,定量限(LOQ)为0.079μg/mL,加标回收率为93.6%~101.8%(n=9),相对标准偏差小于2%。该方法简单、快速、准确,可用于药包材产品中环氧乙烷残留量的检测。

安捷伦8890气相色谱仪，Chromosorb 101  HP 60～80目；玻璃柱长2m*3 mm
Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. has established a headspace gas chromatography method for the analysis of ethylene oxide residues in pharmaceutical packaging products. Headspace gas chromatography was used, Chromosorb 101 HP 60-80 column was used as the separation column, and the detector was a flame ionization detector (FID). The results show that ethylene oxide can be well separated from other chromatographic peaks, and the resolution is greater than 2.0. The linear relationship of ethylene oxide in the concentration range of 0.3982~12.7424 μg/mL is good (R2=1.0). The detection limit of the method (LOD) was 0.025 μg/mL, the limit of quantification (LOQ) was 0.079 μg/mL, and the spiked recoveries ranged from 93.6% to 101.8% (n=9) with a relative standard deviation of less than 2%. The method is simple, rapid and accurate, and can be used for the detection of ethylene oxide residues in pharmaceutical packaging products.

Agilent 8890 gas chromatograph, Chromosorb 101 HP 60-80 mesh; glass column length 2m*3mm