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HPLC法测定复方片剂中依那普利相关物质
引用本文:孙玉明,杨炳华,李岩,孙璐,钟大放.HPLC法测定复方片剂中依那普利相关物质[J].沈阳药科大学学报,2003,20(5):363-366.
作者姓名:孙玉明  杨炳华  李岩  孙璐  钟大放
作者单位:沈阳药科大学药物代谢与药物动力学实验室,辽宁,沈阳,110016
基金项目:国家自然科学基金资助项目 (3 993 0 1 80 )
摘    要:目的建立复方依那普利片剂中依那普利相关物质限度检查的分析方法。方法采用液相色谱质谱联用法 (LC MSn)对依那普利的两种相关物质 (依那普利拉及二酮哌嗪 )进行定性分析 ,采用反相高效液相色谱法 (HPLC UV)对依那普利的 2种相关物质进行定量分析。结果复方依那普利片剂中的各种物质均实现了有效的分离 ,相邻两峰之间的分离度均大于 1 5。结论该方法专属性强 ,可用于制剂中依那普利的含量测定及相关物质的限度检查

关 键 词:LC-MSn  HPLC-UV  依那普利  依那普利拉  二酮哌嗪
文章编号:1006-2858(2003)05-0363-04
修稿时间:2003年1月8日

Determination of the related compounds of enalapril by HPLC
SUN Yu-ming,YANG Bing-hua,LI Yan,SUN Lu,ZHONG Da-fang.Determination of the related compounds of enalapril by HPLC[J].Journal of Shenyang Pharmaceutical University,2003,20(5):363-366.
Authors:SUN Yu-ming  YANG Bing-hua  LI Yan  SUN Lu  ZHONG Da-fang
Abstract:Objective To establish a method for determination of the quantitation of the related compounds in enalapril maleate and hydrochlorothiazide tablets.Method A LC-MS n method was developed for the qualitative analyses of the two related compounds (enalaprilat and diketopiperazine),and a HPLC-UV method was applied to the quantitative assay.Result The two related compounds were well seperated from other peaks,the resolution (R) between any of the peaks was not less than 1.5,and the quantation could be determined accurately.Conclusion The method is selective and can be applied to the determination of enalapril and its related compounds.
Keywords:LC-MS  n  HPLC-UV  enalapril  enalaprilat  diketopiperazine
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