气相色谱法测定磷酸二甲啡烷中有机溶剂残留  

Determination of Residual Organic Solvents in Dimemorfan Phosphate by GC

作　　者：刘薇芝[1] 胡汉昆[1] 郑保根 刘安妮[3] 颜锵 刘萍[1] 

机构地区：[1]武汉大学中南医院药学部,武汉430071 [2]武汉大学第二临床学院 [3]武汉大学经济管理学院 [4]武汉药谷生物工程有限公司

出　　处：《中国药师》2014年第4期563-565,共3页China Pharmacist

基　　金：武汉市科技攻关课题(编号:201260523173-4)

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。Objective：To determine the content of chloroform, ethyl acetate and DMF in dimemorfan phosphate by gas chromatog-raphy （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. 92μg·ml-1 , respectively. The residues of the organ-ic 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.

关 键 词：气相色谱法 磷酸二甲啡烷 有机溶剂残留 

分 类 号：R917[医药卫生—药物分析学]