高效液相色谱法测定非布司他片的含量

Content Determination of Febuxostat Tablets by HPLC

目的建立测定非布司他片含量的高效液相色谱法。方法色谱柱为Kromasil-C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.05%磷酸溶液(80∶20),流速为1.0 mL/min,检测波长为317 nm。结果非布司他质量浓度在32.4～48.6μg/mL范围内与峰面积线性关系良好(r=0.999 0),平均回收率为99.58%,RSD=1.13%。结论该方法简便快速,灵敏、准确,适用于测定非布司他片中非布司他的含量,可作为非布司他制剂的质量控制方法。

Objective To establish an HPLC method for the determination of Febuxostat Tablets. Methods The method was pertormed on the Kromasil-C18 column（250 mm ×4.6mm,5μm） with methanol-0.05% phosphoric acid solution（80：20） as the mobile phase at a flow rate of 1.0 mL/min. The detection wavelength was at 317 nm. Results The linear range of febuxostat was 32.4 -48.6 μg/mL （r =0. 999 0）,the average recovery rate was 99.58%, RSD = 1.13%. Conclusion This method is rapid,sensitive and accurate,which is suitable for determining the febuxostat content in Febuxostat Tablets and can be used as the quality control method of febuxostat preparations