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目的建立顶空气相色谱法评价导管消毒连接器中消毒剂的稳定性试验方法。方法采用顶空气相色谱法对老化前后的3批样品中的异丙醇消毒剂的含量进行测定,用气相色谱-氢火焰离子化检测器进行检测,色谱柱为VF-Wax柱,载气为氮气,柱温50℃保持2min,以20℃/min的速率升至150℃,检测器和进样口温度分别为180℃和250℃;顶空平衡温度80℃,平衡时间30min,外标法定量。结果异丙醇的线性范围为23.25μg·m L-1~372μg·m L-1,相关系数为0.9 9 9 9,加样回收率在94.2%~104.4%之间,样品的重复性(n=6)RSD为1.8%,老化前后三批样品的RSD均小于10%。结论该方法简便、快速、准确,可用于评价导管消毒连接器的稳定性。
Objective To establish a method for evaluating the stability of disinfectants in catheter disinfection connector by headspace gas chromatography. Methods The contents of isopropanol disinfectant in three batches of samples before and after aging were determined by headspace gas chromatography (GC-MS). The gas chromatographic-hydrogen flame ionization detector was used for the detection. The column was VF-Wax with carrier gas of Nitrogen and the column temperature was maintained at 50 ° C for 2min and the temperature was raised to 150 ° C at a rate of 20 ° C / min. The detector and inlet temperatures were 180 ° C and 250 ° C respectively. The headspace equilibrium temperature was 80 ° C and the equilibration time was 30 min. Quantitative. Results The linear range of isopropanol was 23.25μg · m L-1 ~ 372μg · m L-1, the correlation coefficient was 0.9 9 9 9, and the recoveries were between 94.2% and 104.4%. The repeatability (n = 6) The RSD was 1.8%. The RSDs of three batches of samples before and after aging were less than 10%. Conclusion The method is simple, rapid and accurate and can be used to evaluate the stability of catheter disinfection connector.