摘要
目的建立测定棕榈哌泊噻嗪的有关物质的正相高效液相色谱方法。方法采用硅胶柱,以异辛烷-醋酸乙酯-三乙胺(60∶18∶1.3)为流动相。使用Waters 2475荧光检测器,激发波长为283nm,发射波长为485nm。结果经破坏试验、专属性试验、定量限、耐用性试验、重复性试验、稳定性试验等,认为方法可行。结论此方法简便、准确,可用于该药有关物质的检查。
Objective To establish a HPLC method for determination of related substance in pipotiazine palmitate.Methods A SiO2 column（Ultimate） was used with isooctane-acetoacetate-triethylamine（60∶18∶1.3）as the mobile phase.The samples were detected by Waters 2475 fluorescence detector.The excitation and emission wavelength of fluorescence detector were 283nm and 485nm.Results After destruction experiment,specificity experiment,quantitative limit experiment,durability experiment,reproducibility experiment and stability experiment,the method is proved to be feasible.Conclusion The method is simple and accurate.It can be adopted for the examination of impurities in the drug.
出处
《中国药事》
CAS
2012年第1期31-34,共4页
Chinese Pharmaceutical Affairs
基金
国家药典委员会国家药品标准提高研究课题任务2010年版工作(编号药典化发[2010]84号文
项目编号:附件3-903)
