顶空气相色谱法测定盐酸氨溴索中的残留溶剂___

目的：建立盐酸氨溴索中残留溶剂的测定方法。方法：采用HP-1毛细管柱，载气为氮气，顶空进样，进样口温度为 150 ℃，检测器温度为220 ℃，程序升温，分流进样，分流比为1∶1，FID检测器。结果：各溶剂在所考察的浓度范围内均呈现良好的线性关系（甲醇r=0.9998、乙醇r=0.9998、丙酮r=0.9998、二氯甲烷r=0.9998、氯仿r=0.9997），平均回收率在97%～102%之间，精密度、重复性的RSD均小于5.0%，完全符合残留溶剂测定的技术要求。结论：所建立的方法简单、准确、精密度高、重现性好，能用于该原料药中5种残留溶剂的同时测定。

Objective:A headspace-GC method was established for determination of the residual solvents in ambroxol hydrochloride.Method:Using an HP-1 capillary column,with nitrogen as carrier gas and FID as detector.The injector temperature was 150 ℃ and the detector temperature was 220 ℃,temperature program and split injection mode were used.Results:A good linearity was obtained within the designed range of each solvent,the average recoveries were from 97% to 102%,the RSD of precision and accuracy test were all less than 5.0%,they all met the correlative criterion of ChP.Conclusion:This method was proved to be simple and accurate,it has a good reproducibility and can be used to determinate the five residual solvents in ambroxol hydrochloride.