| HPLC法测定硝酸咪康唑栓含量的不确定度分析 |
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| 引用本文： | 雷健 张小松 孙鹏 朱凯 范琦. HPLC法测定硝酸咪康唑栓含量的不确定度分析[J]. 药物分析杂志, 2007, 27(7): 1047-1050 |
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| 作者姓名： | 雷健 张小松 孙鹏 朱凯 范琦 |
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| 作者单位： | 重庆医科大学药学院，重庆市药品检验所 |
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| 摘 要： | 目的:建立 HPLC 法测定硝酸咪康唑栓含量的不确定度分析方法。方法:通过建立 HPLC 含量测定法的数学模型,找出影响不确定度的因素并对各个不确定度分量进行评估。结果:计算各变量的不确定度,由此计算合成不确定度,最终给出了测定结果的扩展不确定度和置信水平。结论:测量不确定度可用于对硝酸咪康唑含量测定结果的评估;建立的方法适用于HPLC 法测定各类制剂含量的不确定度分析。
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| 关 键 词： | 硝酸咪康唑 栓剂 含量 HPLC 不确定度 |
| 文章编号： | 0254-1793（2007）07-1047-04 |
| 修稿时间： | 2006-06-09 |
Uncertainty analysis assay for miconazole nitrate suppositories with HPLC |
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| LEI Jian ,ZHANG Xiao -song,SUN Peng ,ZHU Kai ,FAN Qi. Uncertainty analysis assay for miconazole nitrate suppositories with HPLC[J]. Chinese Journal of Pharmaceutical Analysis, 2007, 27(7): 1047-1050 |
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| Authors: | LEI Jian ZHANG Xiao -song SUN Peng ZHU Kai FAN Qi |
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| Affiliation: | 1. Chongqing University of Medical Science, Chongqing 400016, China; 2. Chongqing Institute of Drug Control, Chongqing 400015, China |
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| Abstract: | Objective:To establish a method for value of uncertainty in assay with HPLC.Methods:The calculation formula for the uncertainty was deduced in the procedure of assay for the suppositories.Results:The uncertainty for each factor was calculated by analyzing the variable parameters among the procedure.The combined uncertainty was finally obtained by synthesizing the uncertainties for the factors.Conclusion:The mathematic model of uncertainty of measurement established in this paper is reasonable and reliable.It is applicable to evaluate the accuracy of assay for suppositories with HPLC. |
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| Keywords: | miconazole nitrate suppositories assay HPLC uncertainty |
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