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目的:建立柱前衍生反应高效液相色谱法测定盐酸乙胺丁醇原料中杂质内消旋盐酸乙胺丁醇(杂质B)。方法:以(R)-(+)-1-苯乙基异氰酸酯为柱前衍生化试剂,采用Inertsil ODS-3(3μm,4.6 mm×100 mm)色谱柱,流动相为甲醇-水(1∶1)和甲醇,梯度洗脱,检测波长为215 nm,流速为1.0 mL·min-1,柱温为40℃。结果:盐酸乙胺丁醇和杂质B的衍生物分离度良好,杂质B最低检出限为0.05μg·mL-1。结论:本方法专属性强,准确,灵敏,可用于盐酸乙胺丁醇原料中有关物质的检查。
OBJECTIVE: To establish a pre - column derivatization reaction for the determination of impurity meclidine hydrochloride (impurity B) in ethambutol hydrochloride starting material by high performance liquid chromatography. Methods: The column was derivatized with (R) - (+) - 1-phenylethyl isocyanate using Inertsil ODS-3 (3 μm, 4.6 mm × 100 mm) as the mobile phase. 1) and methanol. The detection wavelength was 215 nm, the flow rate was 1.0 mL · min-1 and the column temperature was 40 ℃. Results: The separation of ethambutol hydrochloride and impurity B was good and the detection limit of impurity B was 0.05 μg · mL-1. Conclusion: The method is specific, accurate and sensitive and can be used for the determination of related substances in ethambutol hydrochloride raw materials.