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目的采用HPLC法测定恩替卡韦中的有关物质。方法采用ODS-AQ C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相A为乙腈-水(3∶97),流动相B为乙腈,梯度洗脱,流速1.0 m L·min~(-1),检测波长254 nm,柱温35℃。结果恩替卡韦与降解杂质能完全分离,分离度为2.99;检测限和定量限分别为20、68 ng·m L~(-1),精密度良好(RSD=0.73%)。结论所用方法灵敏、准确、操作简便、专属性强,可用于测定恩替卡韦原料药及片剂中的有关物质。
Objective To determine the related substances in entecavir by HPLC. Methods The mobile phase A was acetonitrile-water (3:97), the mobile phase B was acetonitrile and the gradient elution was performed on a ODS-AQ C 18 column (250 mm × 4.6 mm, 5 μm) ~ (-1), detection wavelength 254 nm, column temperature 35 ℃. Results Entecavir was completely separated from degradation impurities with a resolution of 2.99. The limits of detection and quantification were 20,68 ng · m L -1 with good precision (RSD = 0.73%). Conclusion The method used is sensitive, accurate, simple and easy to operate, and can be used for the determination of related substances in the raw materials and tablets of entecavir.