高效液相色谱法测定非布司他片的含量

Determination of febuxostat tablets by HPLC

目的建立高效液相色谱法测定非布司他片含量的方法。方法采用Shimadzu C18色谱柱(150 mm×4.6 mm,5μm),流动相为0.05%乙酸∶乙腈溶液(60∶40,V/V),检测波长为230 nm。结果非布司他的线性范围为2～20 mg.L-1(r=0.999 7),平均回收率为(99.8±1.0)%,RSD=0.96%(n=9)。结论本方法操作简便、灵敏度高、重现性好,可作为非布司他片含量测定的方法。

AIM To establish a method for content determination of febuxostat tablets by high perfor-mance liquid chromatography.METHODS An Shimadzu C18 column（150 mm × 4.6 mm,5 μm）was used with the mobile phase of 0.05% acetic acid and methyl cyanides（60 ∶ 40,V/V）.The UV detection wavelength was 230 nm.RESULTS The linear range of febuxostat was 2-20 mg·L-1（r = 0.999 7）,with average recovery was（99.8 ± 1.0）%,RSD = 0.96%（n = 9）.CONCLUSION The established method is simple,sensitive and reproducible,and suitable for the quality control of febuxostat tablets.