气相色谱法测定一次性使用输液器中环己酮的残留量___

摘要 目的：建立一次性使用输液器中环己酮残留量的测定方法。方法：利用蠕动泵对输液器中的环己酮进行提取，采用气相色谱法进行测定。色谱柱为HP-FFAP石英毛细管柱（30 m×0.53 mm×1.0 μm） 进样口温度200 ℃ 柱温90 ℃ 氢火焰离子化检测器（FID），检测器温度260 ℃ 载气为氮气 流量1.7 mL•min-1 分流比：5∶1 进样体积1.0 μL 以无水乙醇为内标物质，以水为溶剂。结果：环己酮与内标物质在4 min内分离良好 线性相关系数为0.9997 平均回收率为100.1%（n＝9）。结论：该方法简单、快速、准确，可用于一次性使用输液器中环己酮残留量的检测。

Abstract Objective: To establish a method for the determination of residual cyclohexanone in disposable infusion set.Methods:Residual cyclohexanone in disposable infusion set was extracted with circular pump,then it was determined by GC with HP-FFAP capillary column,FID detector and using nitrogen as carrier gas.The injection temperature was 200 ℃,the column temperature was 90 ℃ and the detector temperature was 260 ℃.The flow rate of nitrogen was 1.7 mL•min-1.The split ratio was 5∶1.The injection volume was 1.0 μL.The internal standard was alcohol ，and the solvent was water.Results:The cyclohexanone and internal standard were separated perfectly with 4 min.The correlation coefficient of the linear equation was 0.9997,the average recovery was 100.1%(n=9).Conclusion:The method is simple,rapid and accurate for the determination of residual cyclohexanone in disposable infusion set.

1WANG Yan-ming（王焰民）.Researsh of residual cyclohexanone in disposable infusion set（一次性使用输液器中环己酮的调查）. Chin Pharm（中国药房）,1992，3（6）:45
2JIANG Wen-qiang（蒋文强），L Xia（吕霞）.Determination of residual cyclohexanone in disposable infusion set by UV（一次性使用输液器水浸液中环己酮的分光光度法测定）.Chin J Pharm Anal（药物分析杂志），1998，18（3）：195
3GB 8368（中华人民共和国国家标准8368）.2005
4International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH药品注册的国际技术要求：质量部分).2001.79