High performance liquid chromatography detection method for hydroxylamine residues in medicine

A C18 chromatographic column and a DAD detector are adopted, a mobile phase A is a 0.03% trifluoroacetic acid water-acetonitrile (95: 5) solution, a mobile phase B is a 0.03% trifluoroacetic acid water-acetonitrile (5: 95) solution, and gradient elution is adopted; according to the method, benzaldehyde is used as a derivatization reagent, and residual hydroxylamine in a medicine is derivatized into benzaldoxime; and the amount of hydroxylamine can be rapidly, accurately and quantitatively measured by using a high performance liquid chromatography. Methodology verifies that the quantitation limit meets the residual quantity index requirement, the peak pattern is good, the separation effect is good, the precision is high, the stability is good, and the recovery rate is high. 本发明公开了一种药物中羟胺残留的高效液相色谱检测方法，采用C18色谱柱和DAD检测器，流动相A是0.03％三氟乙酸的水：乙腈(95:5)溶液，流动相B为0.03％三氟乙酸的水：乙腈(5:95)溶液，并采用梯度洗脱；本发明使用苯甲醛作为衍生化试剂，把药物中的残留的羟胺衍生化为苯甲醛肟；使用高效液相色谱法能快速、准确、定量的测出羟胺的量。经方法学验证，本发明定量限满足残留量指标要求，峰型良好，分离效果好，精密度高，稳定性好，回收率高。