气相色谱法测定伊曲康唑传递体有机溶剂残留量  

Determination of Residual Solvents in Itraconazole Transfersomes by Gas Chromatography

作　　者：张宇佳 郑稳生[1] 方夏琴[1] 

机构地区：[1]中国医学科学院北京协和医学院药物研究所,药物传输技术及新型制剂北京市重点实验室,北京100050

出　　处：《医药导报》2013年第8期1075-1077,共3页Herald of Medicine

摘　　要：目的建立测定伊曲康唑传递体中有机溶剂残留量的气相色谱法。方法采用气相色谱法,FID检测器,DB-624(30 m×0.32 mm,1.8μm),载气为氮气,程序升温,进样口温度200℃,检测器温度260℃,以二甲亚砜为溶剂配制对照溶液及供试品溶液。结果两种有机溶剂完全分离,在所考察的浓度范围内具有良好的线性关系,乙醇、三氯甲烷的检测限分别为1.58和2.968μg.mL-1,精密度RSD均<1.0%。平均回收率98%～101%。结论该方法简便灵敏,结果准确可靠,适用于伊曲康唑传递体原料药中有机溶剂残留量检测。Objective To establish a method for the determination of residual solvents in itraconazole transfersomes by gas chromatography （GC）. Methods The detector was FID. The analytical column was DB-624 （30 m×0.32 mm,1.8 μm）. The injector temperature was 200 ℃, and the detector temperature was set at 260 ℃. The column temperature was raised by temperature programming. Nitrogen served as carrier gas and the dimethylsulfoxide （DMSO） as solvent media. Results The two kinds of solvents had a good linearity in the experimental concentration. The detection limit of ethanol and chloroform was 1.58 and 2. 968 μg · mL^-1 ,respectively. The RSD of precision was less than 1.0% for both solvents. The average recovery was 98%- 101%. Conclusion This method was simple, sensitive, accurate and can be used for the detection of residual solvents in itraconazole transfersomes.

关 键 词：伊曲康唑传递体 有机溶剂残留量 色谱法 气相 

分 类 号：R978.5[医药卫生—药品] R927.1[医药卫生—药学]