雷诺嗪有机溶剂残留量的研究

Determination of residual organic solvent in ranolazine

目的:建立雷诺嗪中乙醇、乙酸乙酯两种有机溶剂残留量的测定方法。方法:采用OV-17毛细管色谱柱;FID检测器;检测器温度230℃;进样口温度为200℃;程序升温:初始温度为50℃,保持3 min,以每分钟10℃升至150℃;载气为氮气。结果:两种溶剂在此条件下能有效的分离,且线性关系良好。结论:该方法稳定、准确,可用于雷诺嗪中有机残留量的测定。

Objective： To establish the method for determination of the residual organic solvent,ethanol and ethyl acetate in ranolazine.Methods： OV-17 column was used,with the column temperature programmed.The initial column temperature was 50℃,maintained for 3 min,and then raised to 150℃ with a rate of 10℃/min;Flame ionization detector（FID） was used,the detector temperature was 230℃,and the injector temperature was 200℃.Nitrogen was used as carrier gas.Results： The two organic solvent were completely separated,with the good liner relationship.Conclusion： The method is stable and accurate,and can apply to the determination of the two residual organic solvent in ranolazine.