高效液相色谱法测定伏立诺他的含量及有关物质

目的建立测定伏立诺他含量及有关物质的高效液相色谱法。方法采用Luna-C18色谱柱（250mm×4．6mm，5μm）；流动相为乙腈-0．1％磷酸溶液（27：73及40：60）；流速为1．0ml／min；检测波长为24nm；进样量为20μl；柱温为30℃；样品提取超声时间为20min。结果伏立诺他浓度在24．66-295．92／μg／ml范围内与峰面积呈良好的线性关系，r=O．9999，检测限为10．07ng／ml，其它方法学验证各项指标均良好。伏立诺他对高温与光照较稳定，其酸降解、碱降解、氧化降解产物和苯胺等有关物质与伏立诺他均有良好的分离。结论该方法灵敏度与准确度高，专属性强，可应用于伏立诺他的质量控制。

Determination of Content and Related Substances of Vorinostat by High Performance Liquid Chromatography

Objective To establish a high performance liquid chromatography method for detecting the content of Vorinostat. Methods Luna-Cls column（250 mm x 4.6 mm, 5 p.m） was used, with a mobile phase of acetonitrile-0.1% phosphate buffer （27：73 and 40： 60）, and flow rate of 1.0 ml/min. The detection wavelength was 241 nm, the sample volumn was 20μl, and the column temperature was 30 ℃. The ultraphonic extract time of sample was 20 min. Results The concentration of Vorinostat showed good linearity with peak area in the range of 24.66 - 295.92 μg/ml, r = 0.999 9. The lowest determination limit was 10.07 ng/ml. The other methodology checking indicator were all well. Vorinostat was stable under high temperature and illumination, the degradation product of acid degradation, base degradation, oxidation degradation and the related substances such as aniline were all has high sensitivity and accuracy, good specificity, and can be separated well from Voriinostat. Conclusion The method used for quality control of Vorinostat.