HPLC测定盐酸乙胺丁醇有关物质

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。

Determination of related substances in ethambutol hydrochloride

Objective:To establish an HPLC method to determine meso-ethambutol hydrochloride(impurity B) in ethambutol hydrochloride for pharmaceutical use.Method:The method was conducted on a Inertsil ODS-3 column(3 μm,4.6 mm×100 mm)and coupled UV detector at 215 nm,using a gradient elution by methanol-water(1∶ 1) and methanol as mobile phase.(R)-(+)-1-phenylethyl isocyanate was used as pre-column derivatization.The flow rate was 1.0 mL·min-1and the column temperature was 40 ℃.Result:The resolution between the derivatives of these two compounds was satisfied,and the LOD of them was 0.05 μg·mL-1.Conclusion:This method is specificity,accurate and sensitive,so it can be used for determine the related compounds in ethambutol hydrochloride.