气相色谱法测定他米巴罗汀原料药中4种有机溶剂残留量

摘要

Objective To establish a gas chromatography method for the determination of four kinds of residual organic solvents in tamibarotene. Method The residues of methanol, dichloromethane, n -hexane and ethyl acetate were determined by capillary gas chromatography by using DB-624 as the column (30 m × 0. 53 mm × 1. 0 μm) , high-purity nitrogen as carrier gas and FID as detector. Results The four organic solvents were separated completely,and the separation factors and recoveries were satisfied. Conclusion The method is sensitive,accurate,and suitable for the determination of residual organic solvents in tamibarotene.%目的 建立他米巴罗汀原料药中4种有机溶剂残留量的分离测定方法.方法 采用毛细管气相色谱法,色谱柱为DB-624石英毛细柱(30 m×0.53 mm×1.0 μm),FID检测器,载气为高纯氮气,柱温为程序升温,测定了他米巴罗汀原料药中甲醇、二氯甲烷、正己烷和乙酸乙酯的残留量.结果 4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 建立的方法灵敏、准确,适用于他米巴罗汀原料药中有机溶剂残留量的检测.