[1]荀秀彪,张顺平.高效液相色谱法测定盐酸依托必利片含量的不确定度分析[J].医学信息,2020,33(04):181-183.[doi:10.3969/j.issn.1006-1959.2020.04.062]
　XUN Xiu-biao,ZHANG Shun-ping.Analysis of Uncertainty in Determination of Etopril Hydrochloride Tablets by High Performance Liquid Chromatography[J].Medical Information,2020,33(04):181-183.[doi:10.3969/j.issn.1006-1959.2020.04.062]
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高效液相色谱法测定盐酸依托必利片含量的不确定度分析()
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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
33卷
期数:
2020年04期
页码:
181-183
栏目:
诊疗技术
出版日期:
2020-02-15

文章信息/Info

Title:
Analysis of Uncertainty in Determination of Etopril Hydrochloride Tablets by High Performance Liquid Chromatography
文章编号:
1006-1959（2020）04-0181-03
作者:
荀秀彪; 张顺平
（云南省曲靖市食品药品检验检测中心，云南 曲靖 655000）
Author(s):
XUN Xiu-biao; ZHANG Shun-ping
(Qujing Food and Drug Inspection and Testing Center,Qujing 655000,Yunnan,China)
关键词:
高效液相色谱法; 盐酸伊托必利片; 含量测定; 不确定度
Keywords:
High performance liquid chromatography; Ittopril hydrochloride; Content determination; Uncertainty
分类号:
R286
DOI:
10.3969/j.issn.1006-1959.2020.04.062
文献标志码:
A
摘要:
目的 建立高效液相色谱法（HPLC）测定盐酸伊托必利片含量测量的不确定度评定方法。方法 通过建立高效液相色谱法测定盐酸伊托必利片含量的数学模型，分析不确定度的来源，并对各个不确定度分量、合成不确定度进行评估，得出扩展不确定度。结果 高效液相色谱法测定盐酸伊托必利片含量为99.70%，置信概率P为95.00%时，其扩展不确定度为3.59%，测定结果可以表示为（99.70±3.59）%，k=2。结论 该法可用于高效液相色谱法测定盐酸伊托必利片含量的不确定度分析。
Abstract:
Objective To establish a method for the evaluation of uncertainty in the determination of the content of ittopril hydrochloride by high performance liquid chromatography (HPLC). Methods By establishing a high performance liquid chromatography mathematical model for determining the content of ittopril hydrochloride, the sources of uncertainty were analyzed, and evaluate each uncertainty component and synthetic uncertainty, the extended uncertainty is obtained. Results The high-performance liquid chromatography method for determining the content of itolibril hydrochloride tablets was 99.70%. When the confidence probability P was 95.00%, the expanded uncertainty was 3.59%, the measurement result can be expressed as (99.70±3.59) %,k=2. Conclusion This method can be used for uncertainty analysis of high-performance liquid chromatography determination of ittopril hydrochloride.

参考文献/References:

[1]中华人民共和国药典委员会.中华人民共和国药典临床用药须知(化学药和生物制品卷)[S].2010年版.北京:中国医药科技出版社,383. [2]国家质量技术监督检验检疫总局.JJF1135-2005化学分析测量不确定度评定[S].北京:中国计量出版社,2005. [3]国家质量监督检验检疫总局.JJG196-2006 常用玻璃量器检定规程[S].北京.中国计量出版社,2006. [4]EURACHEM\CITAC GUIDE.量化分析测量不确定度指南[M].北京:中国计量出版社,2003:129. [5]国家质量技术监督局.测量不确定度评定与表示(JJF1059-2012)[S].北京:中国计量出版社,2012.

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更新日期/Last Update: 2020-02-15