HPLC法和TLC法测定羟基脲及羟基脲片中的有关物质

HPLC and TLC determination of related substances in hydroxycarbamide and its tablets

目的:采用高效液相色谱法和薄层色谱法测定羟基脲及羟基脲片中的有关物质和降解产物。方法:HPLC使用Cl8色谱柱(150mm×4.6mm,5μm),以甲醇-水(5∶95)为流动相,流速为0.5mL·min-1;检测波长为214nm。TLC法中薄层板:硅胶G薄层板;展开剂:吡啶-水-乙酸乙酯(2∶2∶10);显色剂:对甲氨基苯甲醛盐酸溶液。结果:各降解产物均可与羟基脲主峰(或主斑点)良好分离,方法的精密度和重复性良好(RSD<0.3%)。结论:经方法学验证,该法灵敏、准确,适用于羟基脲及羟基脲片的有关物质的测定。

Objective：To establish an HPLC method and thin layer chromatography method to determine the related substances and the degradation substances of hydroxycarbamide and its tablets.Methods：A Shimadzu VP-ODS C18 column（250 mm×4.6 mm,5 μm）with UV detection at 214 nm,and methanol-water（5∶95）as the mobile phase was used in HPLC.The flow rate was 0.5 mL·min-1,and the temperature of the column was 35 ℃.Results：Main peak and individual impurity peak were separated wel1.The reproducibility and precision of the method were good（RSD0.3%）.Conclusion：The method has proved to be sensitive and accurate.It is quite suitable to be used in the analysis of related substances of hydroxycarbamide and its tablets.