高效液相色谱法测定非布司他原料药的含量

Determination of the content of febuxostat by high performance liquid chromatography

目的:建立HPLC测定非布司他原料含量的方法。方法:以十八烷基硅烷键合硅胶为填充剂;以0.01mol/L醋酸钠溶液(用磷酸调节pH值至3.0)-乙腈(45∶55)为流动相;检测波长为313nm。结果:在浓度40～60μg/mL)(r=0.9999)范围内,峰面积与浓度呈良好的线性关系,加样回收率99.59%,RSD=0.34%(n=9)。结论:HPLC测定非布司他原料药的含量是可行的、准确的,重现性好,可作为非布司他原料药的含量测定方法。

Objective:To establish the HPLC method for determining the content of Febuxostat.Methods:Octadecylsilane-bonded silica gel was used as the filler;0.01mol/L sodium acetate solution (adjusting pH to 3.0with Phosphoric acid)-acetonitrile(45:55)was used as the mobile phase;detection wavelength was 313nm.Results:In the range of injection volume 40-60μg/mL (r=0.9999),There was a good linear relationship between the peak area and the injection volume.The recovery rate of the sample was 99.59%.and the RSD was 0.34%(n=9).Conclusion:The HPLC determination of Febuxostat raw material content is feasible,accurate,and good reproducibility, can be used as a method for determining the content of Febuxostat raw materials.