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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、7.2~360μg/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。
OBJECTIVE To establish a capillary gas chromatographic method for the simultaneous determination of acetone, dichloromethane, ethyl acetate and tetrahydrofuran in perindopril tert-butylamine salt. Methods DB-624 capillary column was used to program temperature and FID detector. The equilibrium temperature was 80 ℃ and the equilibrium time was 30 min. Results The above solvents showed good linearity in the range of 50-2 500, 6-300, 50-2 500 and 7.2-360 μg / mL, respectively. The recoveries were 103.1%, 100.8%, 101.4% and 102.5%, respectively. The RSD values were 1.2% , 2.4%, 3.6%, 3.7%. Conclusion The chromatographic system can simultaneously determine the residues of four kinds of organic solvents in perindopril tert-butylamine salt.