气相色谱法测定达比加群酯中10种溶剂的残留

Determination of Ten Solvent Residues in Dabigatran Etexilate by Gas Chromatography

目的:建立气相色谱法检测达比加群酯中10种残留溶剂。方法:以Rtx-11.0μm)极性毛细管柱程序升温,以氮气为载气,FID为检测器,进样口温度为200℃,检测器温度为250℃,对达比加群酯中10种残留溶剂(甲醇、乙醇、乙酸乙酯、丙酮、二氯甲烷、正己烷、四氢呋喃、异辛烷、吡啶和甲苯)进行测定。结果:各残留溶剂组分均能被良好分离,各溶剂线性关系良好,精密度RSD均不超过3.50%,平均回收率为96.0%~105.0%。结论:本文建立的方法可用于达比加群酯中残留溶剂的测定。

Objective： To establish a gas chromatographic method for the determination of ten residual solvents in dabigatran etexilate. Methods： The Rtx-1（60 m × 0.32 mm × 1.0 μm） polar capillary column was used to heat up the sample. Nitrogen was used as the carrier gas, FID was used as the detector, the inlet temperature was and the detector temperature was 250 ℃. Ten residual solvents（methanol, ethanol, ethyl acetate, acetone, dichloromethane, hexane, tetrahydrofuran, isooctane, pyridine and toluene） in picarbitol ester were quantified under the above conditions. Results： The residual solvents were well separated, the linear relationships were good, the RSDs were less than 3.50%, and the average recoveries were 96.0%-105.0%. Conclusion： The method demonstrated in this paper can be used for the determination of residual solvents in dabigatran etexilate.