摘要
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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2006年第11期1681-1683,共3页
Chinese Journal of Pharmaceutical Analysis