[关键词]
[摘要]
目的 建立顶空毛细管气相色谱法同时测定培哚普利叔丁胺盐中的丙酮、二氯甲烷、醋酸乙酯、四氢呋喃的残留量。方法 采用DB-624毛细管色谱柱,程序升温,FID检测器,顶空平衡温度80 ℃,平衡时间30 min。结果 上述溶剂分别在50~2 500、6~300、50~2 500、7.2~360 μg/mL线性关系良好,回收率分别为103.1%、100.8%、101.4%、102.5%,RSD值分别为1.2%、2.4%、3.6%、3.7%。结论 本色谱系统可同时测定培哚普利叔丁胺盐中4种有机溶剂的残留。
[Key word]
[Abstract]
Objective A headspace capillary gas chromatography method was established for the determination of acetone, dichlormethane, ethyl acetate, and tetrahydrofuran in perindopril tert-butylamine. Methods DB-624 capillary column was used with temperature program and FID detector, at injection temperature of 80℃ and equilibrium time of 30 min. Results The calibration curves of these solvents were linear in the concentration ranges of 5-2 500, 6-300, 50-2 500, and 7.2-360 μg/ml, respectively. The recoveries were 103.1%, 100.8%, 101.4%, and 102.5%, with RSDs 1.2%, 2.4%,3.6%, and 3.7%. Conclusion The determination of four residual organic solvents in perindopril tert-butylamine can be carried out by headspace capillary GC simultaneously.
[中图分类号]
[基金项目]
国家药典委员会2011年标准提高项目