UPLC法测定单硝酸异山梨酯中的有关物质

Determination of the Related Substances in Isosorbide Mononitrate by UPLC

建立了同时测定单硝酸异山梨酯中7种杂质的超高效液相色谱-紫外检测法。采用BEH C18色谱柱,以0.1%磷酸溶液与乙腈组成的流动相梯度洗脱,流速0.7 ml/min,检测波长210 nm,柱温25℃。结果显示,单硝酸异山梨酯及7种杂质能完全分离,并在测定浓度范围内线性关系良好。单硝酸异山梨酯及各杂质的检测限为21.09~24.34 ng/ml,定量限为63.27~73.01 ng/ml,加样回收率为99.21%~105.11%,准确度良好。该方法操作简单、专属性好、准确度高,可用于单硝酸异山梨酯中有关物质的测定,为质量控制提供参考。

A UPLC-UVD method for simultaneous determination of seven impurities in isosorbide mononitrate was established in this study.The separation was performed on a BEH C18 chromatographic column at 25℃with the mobile phase consisting of 0.1%phosphoric acid and acetonitrile by gradient elution at the flow rate of 0.7 ml/min.The results showed that isosorbide mononitrate and seven impurities could be completely separated and they were linear in the test ranges.The detection limits were 21.09-24.34 ng/ml,the quantitation limits were 63.27-73.01 ng/ml,and the recoveries were 99.21%-105.11%.The method was simple and had good specificity and accuracy,which could be used for determination of the related substances in isosorbide mononitrate and provided a reference for the quality control.