HPLC法测定阿德福韦酯片的含量和有关物质

Determination of Adefovir Dipivoxil Tablets and related substances by HPLC

目的：建立高效液相色谱法测定阿德福韦酯片的含量和有关物质。方法采用HypersilC18色谱柱，以乙腈-水（45∶55）（用磷酸调pH＝4．0）为流动相，检测波长为261nm，流速为1．0mL·min-1。结果阿德福韦酯质量浓度在1．036～62．161μg·mL-1范围内线性关系良好（r＝0．9998），最低检测限为0．24ng，回收率为100．6％。结论该方法准确，灵敏，精密度高，专属性强，可用于阿德福韦酯片的含量测定和有关物质检查。

Objective To establish an HPLC method for the determination of Adefovir Dipivoxil Tablets and its related substances . Method The analytical column was Hypersil C18 and the mobile phase was acetonitrile-water （45∶55） adjusted with phosphoric acid to a pH of 4 .0 .The detection wavelength was 261 nm and the flow rate was 1 .0 mL · min-1 .Results Adefovir dipivoxil was linear in the range from 1 .036 to 62 .161 μg · mL -1 （r=0 .999 8） .The limit of detection was 0 .24 ng and the average recovery was 100 .6% .Conclusion The method was accurate ,sensitive ,precise ,and can be used for the content assay ,as well as the analysis of the related substances in Adefovir Dipivoxil Tablets .