气相色谱法测定富马酸替诺福韦二吡呋酯原料的残留溶剂  

Determination of Residual Organic Solvents in Tenofovir Disoproxil Fumarate by Gas Chromatography

作　　者：王兵 

机构地区：[1]常州制药厂有限公司,江苏常州213018

出　　处：《广东化工》2015年第16期209-209,216,共2页Guangdong Chemical Industry

摘　　要：目的：建立富马酸替诺福韦二吡呋酯中残留有机溶剂的检测方法。方法：采用顶空毛细管气相色谱法,以二甲亚砜为溶解介质,色谱柱为HP-5（30 m＊0.53 mm 2.65 um）,载气为氮气,FID检测器,测定富马酸替诺福韦二吡呋酯中残留的甲醇、异丙醇、叔丁醇、异丙醚、乙酸乙酯。结果：各被测溶剂均能良好分离,各溶剂线性关系良好,精密度RSD均小于10%,平均回收率为90%~110%之间。结论：该法适用于富马酸替诺福韦二吡呋酯原料药的残留溶剂测定。Objective： A method for the determination of residual solvent in Tenofovir Disoproxil Fumarate was established. Methods： The GC was used. The solvent was dimethyl sulfoxide. DB-624（30 m＊0.53 mm 2.65 um） column was used with high purity nitrogen as carrier gas and FID detector. Make an quantitative analysis of the residual solvent in Tenofovir Disoproxil Fumarate including methanol, isopropanol, tert-butyl alcohol, diisopropyl ether and ethyl acetate. Results： Each solvent could be completely separated in chromatogram obtained from systemic suitability test, and the calibration curves of each solvent had good linear relationship, the RSD of precision was less than 10 %, the average recovery was in the range of 90 %~110 %. Conclusion： It can be applied in detection of residual solvents in Tenofovir Disoproxil Fumarate substance.

关 键 词：气相色谱法 残留溶剂 富马酸替诺福韦二吡呋酯 

分 类 号：O65[理学—分析化学]