塞来昔布有关物质的HPLC法测定

Determination of the Related Substances in Celecoxib by HPLC

建立了高效液相色谱法测定塞来昔布原料药中的有关物质。采用Zorbax SB-苯基柱,流动相为乙腈∶0.02 mol/L磷酸二氢钾缓冲液(用磷酸调至p H 3.0)(35∶65),检测波长215 nm。塞来昔布及其4个有关物质在0.1~10μg/ml范围内线性关系良好;有关物质回收率为95.7%~99.3%,RSD为1.23%~1.63%;各有关物质的检测限为0.01μg/ml,定量限为0.03μg/ml。本方法简便准确、重现性好、精密度高,可有效检测塞来昔布中的有关物质,为本品的质量控制提供参考。

An HPLC method was established for the determination of the related substances in celecoxib. The separation was performed on a Zorbax SB-Phenyl column, with the mobile phase of acetonitrile∶0.02 mol/L potassium dihydrogen phosphate buffer（adjusted to p H 3.0 with phosphoric acid）（35∶65）, at the detection wavelength of 215 nm. It was linear for celecoxib and its related substances in the range of 0.1-10 μg/ml. The recoveries for the related substances were 95.7%-99.3%, with RSDs of 1.23%-1.63%. The detection limits of the related substances were 0.01 μg/ml, and the quantitation limits were 0.03 μg/ml. The method is simple, accurate, reproducible, and suitable for the determination of related substances in celecoxib, which provides a reliable method for the quality control of celccoxib.