雷贝拉唑钠中有机溶剂残留的顶空毛细管气相色谱法测定

Determination of Residual Organic Solvents in Rabeprazole Sodium by Headspace Capillary GC

建立了顶空毛细管气相色谱法测定雷贝拉唑钠原药中的有机溶剂残留。采用DB-624毛细管柱,载气为氦气,氢火焰离子化检测器(FID),程序升温。甲醇、丙酮、乙腈、二氯甲烷、甲基叔丁醚、乙酸乙酯、三氯甲烷、正庚烷和甲苯9种溶剂线性关系良好,平均回收率分别为96.8%、103.1%、106.5%、102.8%、103.4%、105.6%、106.5%、107.5%和106.9%,RSD分别为2.0%、1.0%、1.6%、1.4%、1.9%、1.4%、7.0%、1.6%和2.3%。

A headspace capillary GC method was established for the determination of the residual organic solvents in rabeprazole sodium. A DB-624 capillary column was used, with helium as the carrier gas and FID as the detector in temperature program mode. The calibration curves of methanol, acetone, acetonitrile, dichloromethane, methyl tert-butyl ether, ethyl acetate, chloroform, n-heptane and toluene were linear. Their average recoveries were 96.8 %, 103.1%, 106.5%, 102.8%, 103.4%, 105.6%, 106.5%, 107.5% and 106.9%, withRSDs of 2.0%, 1.0%, 1.6%, 1.4%, 1.9%, 1.4%, 7.0%, 1.6% and 2.3%, respectively.