气相色谱法测定米格列奈钙中6种有机溶剂残留量

Capillary gas chromatographic determination of six residual solvents in mitiglinide calcium

目的:建立米格列奈钙中6种有机溶剂残留量的分离测定方法。方法:采用顶空进样毛细管气相色谱法,FID 检测器,色谱柱为 HP-INNOwax 毛细管柱,载气为氮气,柱温30℃,测定了米格列奈钙原料中乙醚、四氢呋喃、乙酸乙酯、甲醇、二氯甲烷和乙醇的残留量。结果:6种有机溶剂完全分离,在所考察范围内线性关系良好,加样回收率均得到满意结果。结论:本实验建立的方法灵敏、准确,适用于米格列奈钙中有机溶剂残留量的检测。

Objective：To establish a method for determination of six residual solvents in mitiglinide calcium. Methods ：The residual solvents in mitiglinide calcium which are ether, tetrahydrofuran, ethyl acetate, methanol, dichloromethane, ethanol were quantitatively determined by headspace GC on HP- INNOWax column, with FID detector, nitrogen as the carries gas, the intial temperature was kept at 30℃. Results：Six residual solvents were completely separated. There were good linearity and the recoveries were satisfied. Conclusion：Tile method is sensitive, accurate and can be used for quality control.