HPLC法测定硝酸异山梨酯缓释片的有关物质

目的对硝酸异山梨酯缓释片有关物质进行测定。方法采用高效液相色谱,用Agilenteclipse XDB-C18柱(4.6×250mm,5μm),流动相为水-甲醇(70∶30);流速为1mL·min-1;检测波长为210nm;柱温为30℃。结果 2-单硝酸异山梨酯线性范围为0.4～20μg.mL-1(r=1.0000),平均回收率为100.3%,RSD为2.2%;单硝酸异山梨酯线性范围为0.4～20μg.mL-1(r=1.0000),平均回收率为101.6%,RSD为2.1%。结论本方法简便、准确,能够有效测定硝酸异山梨酯缓释片的有关物质。

Determination of related substances in Isosorbide Dinitrate Sustained Release Tablets by HPLC

OBJECTIVE To establish an analysis method for determination of related substances in Isosorbide Dinitrate Sustained Release Tablets.METHODS HPLC method was used.The chromatography conditions ware as follows：the Agilent eclipse XDB-C18 column（250mm × 4.6mm,5μm）was used;The mobile phase was water-methanol（70∶30）;The follow rate was 1.0mL·min-1;The detection wavelength was 210nm;The temperature was 30℃.RESULTS The linear range of 2-isosorbide mononitrate was 0.4～20μg·mL-1（r=1.0000）,the average recovery rate of 2-isosorbide mononitrate was 100.3%,the RSD was 2.2%.The linear range of isosorbide mononitrate was 0.4～20μg·mL-1（r=1.0000）,the average recovery rate of isosorbide mononitrate was 101.6%,the RSD was 2.1%.CONCLUSION This method was simple and accurate.It can effectivly detemination related substances in Isosorbide Dinitrate Sustained Release Tablets.