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目的:建立测定盐酸雷诺嗪中有机溶剂残留的顶空毛细管气相色谱法。方法:DB-624柱(固定液:6%氰丙基苯基- 94%二甲基聚氧硅烷)(30m×0.32mm×1.8μm);氢火焰离子化检测器(FID),程序升温。结果:7种溶剂甲醇、乙醇、乙醚、二氯甲烷、乙酸乙酯、1,4-二氧六环、甲苯在此条件下能有效分离,且线性关系良好。平均回收率为98.1%-105.5%,RSD为1.1～3.7%(n=6)。结论:方法简单,准确,灵敏,适用于盐酸雷诺嗪中有机溶剂残留物的测定。
Objective: To establish a capillary gas chromatographic method for the determination of organic solvents in ranolazine hydrochloride. Methods: DB-624 column (fixative: 6% cyanopropyl phenyl-94% dimethylpolysiloxane) (30m × 0.32mm × 1.8μm); hydrogen flame ionization detector (FID) Results: The seven solvents methanol, ethanol, ether, dichloromethane, ethyl acetate, 1,4-dioxane and toluene were effectively separated under these conditions, and the linear relationship was good. The average recovery was 98.1% -105.5% with a RSD of 1.1-3.7% (n = 6). Conclusion: The method is simple, accurate and sensitive and is suitable for the determination of organic solvent residues in ranolazine hydrochloride.