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目的:建立了酒石酸布托啡诺中残留有机溶剂甲醇、丙酮、乙醚、二氯甲烷、氯仿、四氢呋喃的分离测定方法。方法:采用顶空毛细管气相色谱法,色谱柱为ZB-1,检测器为FID,水为溶解介质,乙酸乙酯为内标。结果:甲醇、丙酮、乙醚、二氯甲烷、氯仿、四氢呋喃的线性范围分别为1.811~394.6,1.015~389.4,0.130~407.2,0.447~198.3,1.776~100.6,0.341~201.8μg.mL-1;甲醇、丙酮、乙醚、二氯甲烷、氯仿、四氢呋喃的平均回收率分别为97.2%,98.8%,102.5%,102.3%,100.3%,96.4%;相对标准偏差均不超过5.0%(n=6)。结论:该方法简单、准确、灵敏度高、重复性好,适用于酒石酸布托啡诺中的有机溶剂残留量的测定。
OBJECTIVE: To establish a method for the separation and determination of residual organic solvents such as methanol, acetone, ether, dichloromethane, chloroform and tetrahydrofuran in Butorphanol tartrate. Methods: Headspace capillary gas chromatography was used. The column was ZB-1, the detector was FID, water was the dissolution medium and ethyl acetate was the internal standard. Results: The linear ranges of methanol, acetone, ether, dichloromethane, chloroform and tetrahydrofuran were 1.811 ~ 394.6, 1.015 ~ 389.4, 0.130 ~ 407.2, 0.447 ~ 198.3, 1.776 ~ 100.6 and 0.341 ~ 201.8μg.mL- The average recoveries of acetone, ether, dichloromethane, chloroform and tetrahydrofuran were 97.2%, 98.8%, 102.5%, 102.3%, 100.3% and 96.4%, respectively. The relative standard deviations did not exceed 5.0% (n = 6). Conclusion: The method is simple, accurate, sensitive and reproducible. It is suitable for the determination of organic solvent residues in Butorphanol tartrate.