雷美替胺中有机溶剂残留的HS-GC法测定

Determination of Residual Organic Solvents in Ramelteon by HS-GC

建立了顶空气相色谱法同时测定雷美替胺中甲醇、乙醇、丙酮、石油醚（bp 60～90℃）、乙酸乙酯、三乙胺和甲苯7种有机溶剂的残留量.以N,N-二甲基甲酰胺为溶剂,使用Agilent DB-624毛细管色谱柱,氢火焰离子化检测器,程序升温.7种有机溶剂完全分离,在所考察的浓度范围内线性关系良好,平均回收率为99％～102％,RSD＜2.30％.

A headspace gas chromatography （HS-GC） method was established for the determination of seven residual organic solvents in ramelteon including methanol, ethanol, acetone, petroleum ether （bp 60 - 90 ℃）, ethyl acetate, triethylamine and toluene. An Agilent DB-624 capillary column was used with flame ionization detector and temperature programmed control. DMF was chosen as the solvent. The seven solvents were completely separated, and their linearities were satisfied. The average recoveries were 99 % - 102 %, with RSDs less than 2.30 %.