【摘要】 目的 :建立测定阿立哌唑片剂中阿立哌唑及有关物质的检测方法。方法 :采用反相高效液相色谱法 ,色谱柱为十八烷基硅烷键合硅胶柱 ,流动相为 0 .0 5mol·L-1 磷酸二氢钠水溶液 (含 1%三乙胺 ,磷酸调 pH至 5 .5 ) 乙腈 (5 0∶5 0 ) ,检测波长为2 17nm ,流速为 1.0ml·min-1 。结果 :阿立哌唑在 4.10 6～ 41.0 60mg·L-1 浓度范围内峰面积有良好线性关系 ,平均回收率为99 .90 %(n =9) ,重复性试验的相对标准偏差为 0 .82 %(n =6) ,最低检出限量为 0 .5 1ng ,有关物质与主药有较好的分离度。结论 :此法简单、专属性强、重现性好、结果准确可靠 ,适用于阿立哌唑片的质量控制。更多还原

【Abstract】 Objective To develop a method for determination of aripiprazole tablets and its related substances.Methods The RP-HPLC was performed on a Kromasil C 18 column.The mobile phase consisted of acetonitrile-watercontaining 1%TEA adjusted to pH5.5 with H₃PO₄（50∶50）.The UV detection was set at 217-nm.The flow rate was 1.0-ml·min -1.Results A good linearity was in the concentration range of 4.106～41.0602!mg·L -1.The recovery in tablets was 99.90%（n=9）.The RSD for reproducibility was 0.82%（n=6）.The detection limit was 0.51-ng.Conclusion The method is simple ,accurate,and can be used in quality control of aripiprazole tablets.更多还原