HPLC法测定非布司他的含量及有关物质Determination of content of febuxostat and its related substances by HPLC
张聪,王绍杰,麻荣丽,孟萍,张天虹
ZHANG Cong1,WANG Shao-jie2,MA Rong-li1,MENG Ping1,ZHANG Tian-hong1 (1.School of Pharmacy
摘要(Abstract)：
目的建立测定非布司他原料药含量和有关物质的HPLC方法。方法采用Diamond ODS-C18色谱柱(200 mm×4.6 mm,5μm),流动相为甲醇-乙腈-质量分数为0.05%的磷酸溶液(体积比为24∶46∶30),流速为1.0 mL.min-1,UV检测波长为315 nm,柱温为35℃。结果非布司他在15.7~94.3 mg.L-1内线性关系良好(r=0.999 8),平均回收率为100.5%(RSD=1.0%)。非布司他和其有关物质得到良好分离,检测限为0.5 ng。结论 HPLC法可用于非布司他含量测定和有关物质检测。
Objective To establish an HPLC method for determining the content of febuxostat and its related substances.Methods The determination of febuxostat and the separation of its related substances was performed on a C18 column(200 mm ×4.6 mm,5 μm).The mobile phase was methanol-acetonitrile-0.05%(φ)phosphoric acid(V∶V∶V=24∶46∶30).The flow rate was 1.0 mL·min-1.Ultraviolet absorption detector was set at 315 nm and column temperature was 35 ℃.Results The linear range of febuxostat was between 15.7 and 94.3 mg·L-1(r=0.999 8).The average recovery was 100.5%with RSD of 1.0%.The related substances of febuxostat could be completely separated from febuxostat.The limit of detection(LOD)was 0.5 ng.Conclusions The method is simple and accurate for quality control of the febuxostat.
关键词(KeyWords)：
非布司他;高效液相色谱法;有关物质
febuxostat;HPLC;related substance
基金项目(Foundation):
作者(Author):
张聪,王绍杰,麻荣丽,孟萍,张天虹
ZHANG Cong1,WANG Shao-jie2,MA Rong-li1,MENG Ping1,ZHANG Tian-hong1 (1.School of Pharmacy
DOI: 10.14066/j.cnki.cn21-1349/r.2010.08.013
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