【摘要】 目的:采用气相色谱法测定磷酸二甲啡烷原料药中的乙酸乙酯、三氯甲烷和N,N-二甲基甲酰胺(DMF)3种有机溶剂的残留量。方法:采用毛细管气相色谱法,PEG-20M柱,程序升温,以水为溶剂,FID检测器,对乙酸乙酯、三氯甲烷和DMF的残留量进行检测。结果:3种有机溶剂基本实现基线分离且线性关系良好(r均在0.999 0以上),上述3种溶剂残留的检出限范围分别为0.63,0.60和8.92μg·ml-1。3批样品中3种有机溶剂的残留量均符合ICH的规定。结论:该检测方法灵敏、准确、可靠,可用于磷酸二甲啡烷原料的质量控制。更多还原

【Abstract】 Objective: To determine the content of chloroform,ethyl acetate and DMF in dimemorfan phosphate by gas chromatography( GC). Methods: The capillary gas chromatography was used with a PEG-20M column,programmed temperature,water as the solvent and FID as the detector. Results: The three organic solvents were separated and showed good linear relationship( r > 0. 999 0).The detection limit of chloroform,ethyl acetate and DMF was 0. 63,0. 60 and 8. 92 μg·ml- 1,respectively. The residues of the organic solvents in three batches of the samples all met with the requirements of ICH. Conclusion: The method is sensitive,accurate and reliable,and can be used in the quality control of dimemorfan phosphate.更多还原