毛细管气相色谱法测定普拉格雷中的有机溶剂残留量

Determination of residual organic solvents in prasugrel by capillary gas chromatography

目的建立毛细管气相色谱法测定普拉格雷中的有机溶剂残留量。方法用DB624毛细管气相色谱柱,FID检测器,以丙酮为内标进行测定。结果乙醇、乙醚、二氯甲烷、乙酸乙酯的线性范围分别为50～800(r=0.999 5)、50～800(r=0.999 1)、6～96(r=0.999 4)、50～800 mg.L-1(r=0.999 6);乙醇、乙醚、二氯甲烷、乙酸乙酯的平均回收率分别为99.51%、98.97%、99.25%、99.32%;RSD为1.25%、1.14%、1.23%、1.05%(n=9)。结论本方法适用于普拉格雷中的有机溶剂残留量的测定。

Objective To develop a gas chromatography method for the determination of residual organic solvents in prasugrel.Methods The samples w ere injected into DB624 capillary column and analyzed w ith FID detector using acetone as the internal standard.Results The linear ranges of ethanol,ethyl ether,dichloromethane,ethyl acetate w ere 50-800 mg.L-1（r =0.999 5）,50-800 mg.L-1（r =0.999 1）,6-96 mg.L-1（r = 0.999 4）,50-800 mg.L-1（r = 0.999 6） respectively.The recoveries were 99.51%,98.97%,99.25%,99.32%;RSD 1.25%,1.14%,1.23%,1.05%（n = 9） respectively.Conclusions The method is simple,accurate and sensitive w ith good reproducibility.It can be used for the determination of the residual organic solvents in prasugrel.