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HPLC法测定棕榈哌泊噻嗪的有关物质
引用本文:肖菁,潘震宇,田洪,何晓艳,朱剑波. HPLC法测定棕榈哌泊噻嗪的有关物质[J]. 中国药事, 2012, 26(1): 31-34
作者姓名:肖菁  潘震宇  田洪  何晓艳  朱剑波
作者单位:1. 湖南省食品药品检验研究院,长沙,410001
2. 湖南师范大学化学化工学院
基金项目: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)
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.

关 键 词:正相高效液相色谱法  棕榈哌泊噻嗪  荧光检测器  有关物质

Determination of Related Substances in Pipotiazine Palmitate by HPLC
Xiao Jing , Pan Zhenyu , Tian Hong , He Xiaoyan , Zhu Jianbo. Determination of Related Substances in Pipotiazine Palmitate by HPLC[J]. Chinese Pharmaceutical Affairs, 2012, 26(1): 31-34
Authors:Xiao Jing    Pan Zhenyu    Tian Hong    He Xiaoyan    Zhu Jianbo
Affiliation:1(Hunan Institute for Food and Drug Control,Changsha 410001;1College of Chemistry and Chemical Engineering,Hunan Normal University)
Abstract: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.
Keywords:HPLC  Pipotiazine palmitate  fluorescence detector  related substance
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