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机构地区:[1]江苏恒瑞医药股份有限公司,江苏连云港222002
出 处:《中国实验方剂学杂志》2009年第11期23-25,共3页Chinese Journal of Experimental Traditional Medical Formulae
摘 要: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 develop a headspace gas chromatography method for the residual organic solvents in butorphanol tartrate. Methods: The sample was injected into ZB-1 capillary column by headspace sampler and analysed with FID detector using ethylacetate as the internal standard and H20 as the solvent. Results: Methanol, acetone, dichloromethane, ether, chloroform, tetrahydrofuran were linear at the ranges of 1.811 -394.6μg·mL^-1, 1.015 - 389.41,0.130 - 407.2, 0.447 - 198.3.776 - 100.6, 0.341 - 201.8 μg·mL^-1, respectively; The recoveries were 97.2%, 98.8%, 102.5%, 102.3%, 100.3%, 96.4% respectively. Each of the relative standard deviations was no more than 5.0%. Conclusion: The method is simple, accurate and sensitive with good reproducibility. It can be used for the determination of the residual organic solvents in butorphanol tartrate.
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