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目的:建立毛细管柱气相色谱法测定恩替卡韦中残留的有机溶剂。方法:采用HP-624毛细管色谱柱、顶空进样、氢火焰离子化检测器,进样口温度为250℃,检测器温度为300℃,柱温为80℃保持7 min,再以20℃/min升至220℃。结果:甲醇、乙醇、二氯甲烷、叔丁基甲基醚、正己烷、乙酸乙酯、四氢呋喃与甲苯相邻峰间的分离度及检测灵敏度均符合要求。结论:该法简便、快速、灵敏、结果准确可靠,可用于恩替卡韦中残留有机溶剂的测定。
Objective: To establish a capillary gas chromatographic method for the determination of residual organic solvents in entecavir. Methods: HP-624 capillary column, headspace sampling and flame ionization detector were used. The inlet temperature was 250 ℃, the detector temperature was 300 ℃, the column temperature was 80 ℃ for 7 min, and then the temperature was 20 ℃ / min to 220 ° C. Results: The separation and detection sensitivity between adjacent peaks of methanol, ethanol, methylene chloride, tert-butyl methyl ether, n-hexane, ethyl acetate, tetrahydrofuran and toluene all met the requirements. Conclusion: The method is simple, rapid, sensitive and accurate. It can be used for the determination of residual organic solvents in entecavir.