文章摘要
邹文博,尹利辉,胡昌勤.应用粉末X射线衍射法测定地氯雷他定中晶型Ⅰ和晶型Ⅱ的比例[J].中国药事,2018,32(5):637-641
应用粉末X射线衍射法测定地氯雷他定中晶型Ⅰ和晶型Ⅱ的比例
Quantitative Analysis of Weight Ratio of the Polymorphic FormⅠand FormⅡin Desloratadine by X-ray Powder Diffraction
投稿时间:2017-11-01  
DOI:10.16153/j.1002-7777.2018.05.011
中文关键词: 粉末X射线衍射法  地氯雷他定  晶型
英文关键词: X-ray powder diffraction  desloratadine  polymorphic form
基金项目:
作者单位E-mail
邹文博 中国食品药品检定研究院, 北京 102629  
尹利辉 中国食品药品检定研究院, 北京 102629 yinlihui@nifdc.org.cn 
胡昌勤 中国食品药品检定研究院, 北京 102629  
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中文摘要:
      目的:用粉末X射线衍射法测定地氯雷他定原料中晶型Ⅰ和晶型Ⅱ所占重量百分比。方法:将晶型Ⅰ和晶型Ⅱ对照品按照5种不同比例混合后测定,以二者特征峰面积比对重量比绘制标准曲线,采用内标法和标准加入法相结合的方法计算两种晶型所占重量百分比。结果:线性方程为y=2.3205x-1.5641,r=0.9986,3批样品中晶型Ⅰ和晶型Ⅱ的百分比分别为94.8%,5.2%;94.5%,5.5%;92.8%,7.2%。结论:粉末X衍射法可以用于地氯雷他定中晶型Ⅰ和晶型Ⅱ的定量分析。
英文摘要:
      Objective:To determine the weight ratio of the polymorphic form I and form Ⅱ of desloratadine by using X-ray powder diffraction. Methods:The polymorphic form I and form Ⅱ reference were mixed according to fve different ratios before the quantitative analysis. A standard curve was drawn by using the ratio of characteristic peak area to weight ratio of the two polymorphic forms. Internal standard method and standard addition method were combined to calculate the weight ratio of polymorphic form I and form Ⅱ. Results:The linear equation was y=2.3205x-1.5641, r=0.9986. The weight percentages of polymorphic form I and form Ⅱ of three batches of samples were 94.8%, 5.2%; 94.5%, 5.5%; 92.8%, 7.2% respectively. Conclusion:X-ray powder diffraction can be used for quantitative analysis of the polymorphic form I and form Ⅱ of desloratadine.
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