乙酸奥曲肽中有机溶剂残留量的毛细管GC测定

Determination of Residual Organic Solvents in Octreotide Acetate by Capillary GC

建立了毛细管气相色谱法测定乙酸奥曲肽中有机溶剂乙醚、甲醇、二氯甲烷、N,N-二甲基甲酰胺的含量。用HP-Innowax毛细管柱,程序升温的方法。各组分的线性范围分别为25～300、25～300、15～180和25～300μg/ml(r均大于0.999)。平均回收率分别为99.7%、99.5%、99.3%和99.2%。检测限分别为1、1、0.6和1ng。

A capillary GC method for determination of residual organic solvents ethyl ether, methanol, dichloromethaneand DMFin octreotideacetatewasestablished.A HP-Innowax capillary column was used with temperature programmed control. The calibration curves of four solvents were linear in the concentration ranges of 25-300, 25-300, 15-180 and 25-300μg/ml(r > 0.999), respectively. The average recoveries were 99.7%, 99.5%, 99.3% and 99.2%, respectively. The detection limits were 1, 1, 0.6 and 1ng, respectively.