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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 capillary gas chromatographic method was developed for the determination of residual organic solvents in sodium rabeprazole sodium. Using DB-624 capillary column, the carrier gas is helium, hydrogen flame ionization detector (FID), the program temperature. The linear relationship was obtained between methanol, acetone, acetonitrile, dichloromethane, methyl tert-butyl ether, ethyl acetate, trichloromethane, n-heptane and toluene with the average recoveries of 96.8%, 103.1%, 106.5% 102.8%, 103.4%, 105.6%, 106.5%, 107.5% and 106.9% respectively. The RSDs were 2.0%, 1.0%, 1.6%, 1.4%, 1.9%, 1.4%, 7.0%, 1.6% and 2.3% respectively.