目的 建立頂空毛細管氣相色譜法同時測定培哚普利叔丁胺鹽中的丙酮、二氯甲烷、醋酸乙酯、四氫呋喃的殘留量。方法 采用DB-624毛細管色譜柱，程序升溫，F(xiàn)ID檢測器，頂空平衡溫度80 ℃，平衡時間30 min。結果 上述溶劑分別在50～2 500、6～300、50～2 500、7.2～360 μg/mL線性關系良好，回收率分別為103.1%、100.8%、101.4%、102.5%，RSD值分別為1.2%、2.4%、3.6%、3.7%。結論 本色譜系統(tǒng)可同時測定培哚普利叔丁胺鹽中4種有機溶劑的殘留。

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.

國家藥典委員會2011年標準提高項目