顶空GC测定缬沙坦原料有机溶剂残留量

目的建立了缬沙坦原料中几种有机溶剂残留量的测定方法。方法采用顶空气相色谱法,载气为氮气,FID检测器,色谱柱为Agilent DB-624毛细管柱,程序升温,检测缬沙坦中甲醇、二氯甲烷、正己烷、乙酸乙酯、三氯甲烷、环己烷、甲苯、二甲苯的残留量。结果几种溶剂完全分离,在所考察的线性范围内具有良好的线性关系,相关系数均在0.999以上,平均回收率均在103.0%-109.2%范围内,RSD在1.4%-4.7%之间。结论本法简便、快速、准确,适用于缬沙坦中有机溶剂残留量的测定。

Determination of Residual Solvents in Valsartan by Head-space GC

Objective A head-space capillary gas chromatography method for separating and determining residual organic solvents was established. Methods An Agilent DB-624 capillary column was used with nitrogen as carrier gas and FID as detector. The organic residues including methanol, dichloromethane, n-hexane, acetidin, chloroform, cyclohexane, toluene, dimethyl benzene were separated and determined. Results There was good linear relationship in the concentration range measured （r = 0. 999） . The average recoveries were 103.0- 109.2% and RSD s were 1.4%- 4.7%. Conclusions The method is simple, rapid and accurate. It can be used for the determination of various organic residuals in Valsartan.