反相高效液相色谱法测定伏立诺他含量和有关物质

Determination of vorinostat and its related substances by RP-HPLC

目的:建立伏立诺他含量及有关物质的反相高效液相色谱测定方法。方法:采用Kromasil C18色谱柱(250 mm×4.6 mm,5μm);含量测定以0.1%磷酸溶液(三乙胺调节pH值至3.0)-乙腈(70∶30)为流动相,有关物质采用梯度洗脱;流速为1 mL.min-1;检测波长为241 nm。结果:伏立诺他与各杂质之间均达到良好分离,伏立诺他在5.3～266μg.mL-1范围内呈良好的线性关系(r=1),其最低检测限为0.3 ng(S/N=3)。结论:该方法简便、准确、可靠,适用于伏立诺他的质量控制。

Objective： To establish an RP-HPLC method for determination of vorinostat and its related substances.Methods： A Kromasil-C18 column（250 mm×4.6 mm,5 μm） was used and the mobile phase was 0.1% H3PO4（pH 3.0 adjusted by triethanolamine）-acetonitrile（70∶30） for determination of vorinostat.Gradient elution was programmed for detecting related substances.The flow rate was 1.0 mL·min-1 and the detection wavelength was 241 nm.Results： Vorinostat was completely separated from the 5 known impurities.The linear range of vorinostat was 5.3~266 μg·mL-1（r=1） and the limit of detection was 0.3 ng（S/N=3）.Conclusion： The method is simple,accurate and reliable for the quality control of vorinostat.