气相色谱法测定预充注射式无菌溶药器中环氧乙烷残留量

Residual quantity determination of epoxyethane in prefilled injection asepsis drug dissolution utensil

目的：探讨气相色谱法测定预充注射无菌溶药器中环氧乙烷残留量的方法。方法：顶空气相色谱法。色谱柱为ZB-WAX毛细管柱（0．32mmx30mx0．25umDF）；氢火焰离子化检测器（FID）；柱温80℃；气化室温度200℃；检测器温度250℃；氮气为载气；分流比1：5。结果：环氧乙烷在1-10ug／mL范围内呈良好的线性关系（r=O．992），平均回收率为99．45％，RSD为O．65％。结论：本方法操作简便、快速、准确，可作为预充注射无菌溶药器中环氧乙烷残留量的测定方法。

To establish a GC metho for the determination of residual quanmy of epoxyemane in prefilled injection asepsis drug dissolution utensiLMethods：Headspace gas chromatography was used with the PEG-20M capillary column （0.32 mmx30m, 0.25 umDF） at 80℃.The temperature of aerification room： 200℃ ;the temperature of detector： 250℃ ;The carrier gas：helium.The split ratio：l：5.Results ：The good linearity was obtained over the range of 1-10μg/mL （r=0.992）,the average recovery rate was 99.45% ,RSD 0.65%.Conclusion ：This method is accurate ,rapid and accurate ,which can be applied to determine the residual quantity of epoxyethane in prefilled injection asepsis drug dissolution residual.