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目的建立HPLC法测定非布索坦片的含量,为非布索坦片的质量控制和质量标准的建立提供参考。方法采用HPLC法,色谱条件:Kromasil C18色谱柱(250mm×4.6mm,5μm);流动相为乙腈-0.1%甲酸(55:45);检测波长:317nm;流速:1ml·min-1;柱温:30℃。结果非布索坦在20～400μg·ml-1的浓度范围内与峰面积呈良好的线性关系(r=0.9996),最低检出限为0.8ng,3个浓度的回收率分别为99.2%、99.8%、99.4%;RSD分别为0.56%、033%、0.40%。结论本方法操作简便、准确、灵敏,适用于非布索坦片的含量测定,结果可靠。
OBJECTIVE To establish a HPLC method for the determination of febuxostat tablets and provide a reference for the quality control and quality standard of febuxostat tablets. Methods The chromatographic conditions were as follows: Kromasil C18 column (250 mm × 4.6 mm, 5 μm); the mobile phase was acetonitrile-0.1% formic acid (55:45); the detection wavelength was 317 nm; the flow rate was 1 ml · min- : 30 ° C. Results The concentration of febuxostat in the concentration range of 20 ~ 400μg · ml-1 showed a good linear relationship with the peak area (r = 0.9996), the minimum detectable limit was 0.8ng, the recoveries of the three concentrations were 99.2% 99.8% and 99.4% respectively; RSD was 0.56%, 033% and 0.40% respectively. Conclusion The method is simple, accurate and sensitive and is suitable for the determination of febuxostat tablets with reliable results.