高效液相色谱法测定泛昔洛韦片有关物质

Determination of the Related Substances in Famciclovir Tablets by HPLC

建立了高效液相色谱法分离测定泛昔洛韦片的有关物质的方法。采用Aichrombond-AQ C18(4.6 mm×150 mm,5μm)色谱柱;流动相:乙腈-0.02 mol/L磷酸二氢钾溶液(20∶80);流速:1.0 mL/min;检测波长:221 nm;进样量:20μL。泛昔洛韦色谱保留时间约为10 min,与其有关物质分离度良好。该法准确、灵敏度高,可有效地控制该药品有关物质。

The RP - HPLC method for determination of related substances in famciclovir tablets was developed. The chromatographic analysis was performed on Aichrombond -AQ Cls （4.6×150mm, 5 μm）column, the moble phase con- sisted of acetonitrile 0.02 mol/L, potassium dihydrogen phosphate solution, （20 ： 80）. the flow rate was 1.0 mL/min. and detection wavelength was at 221 nm, with 20 μL injection volume. The retention time of Fameiclovir was about 10 min, and the resolution of Famciclovir with related compounds was good. The method was convenient and accurate, and it can be used to control the related substance of Famciclovir Tablets.