超高效液相色谱法测定非布司他片的溶出度

Dissolution Determination of Febuxostat Tablets By UPLC

目的：建立超高效液相色谱法测定非布司他片溶出度的方法。方法：采用桨法,p H6.8的磷酸盐缓冲液为溶出介质,转速为每分钟50转,30 min取样,采用超高效液相色谱法测定非布司他的溶出量。结果：在5.05~80.80μg·m L-1浓度范围内呈良好的线性关系（r=0.9999）,平均回收率为100.24%。3批样品在30min时的溶出度均超过标示量的80%。f2因子测定结果表明3批制剂与1批市售制剂的溶出过程相似。结论：本方法简便、快速、准确,适合测定非布司他片的溶出度。

Objective：To establish a method of the dissolution determination of Febuxostat tablets. Method：Paddle method was adopted. Using phosphate buffer with p H=6.8 as the solvent,the rotation speed at 50 r·min-1,UPLC method was used to determine the content. Result：The assay displayed a good linearity over the concentration range of 5.05~80.80μg·m L-1（r=0.9999）,the average recoverywas 100.24%. f2 of self-made products and commercial product showed that their dissolution procedure were similar. Conclusion：The method is rapid and accurate. It can be applied to determine dissolution of Febuxostat tablets.