[1]荀秀彪,張順平.高效液相色譜法測定鹽酸依托必利片含量的不確定度分析[J].醫學信息,2020,(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,(04):181-183.[doi:10.3969/j.issn.1006-1959.2020.04.062]
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高效液相色譜法測定鹽酸依托必利片含量的不確定度分析()
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醫學信息[ISSN:1006-1959/CN:61-1278/R]

卷:
期數:
2020年04期
頁碼:
181-183
欄目:
診療技術
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
文章編號:
1006-1959(2020)04-0181-03
作者:
荀秀彪張順平
(云南省曲靖市食品藥品檢驗檢測中心,云南 曲靖 655000)
Author(s):
XUN Xiu-biaoZHANG Shun-ping
(Qujing Food and Drug Inspection and Testing Center,Qujing 655000,Yunnan,China)
關鍵詞:
高效液相色譜法鹽酸伊托必利片含量測定不確定度
Keywords:
High performance liquid chromatographyIttopril hydrochlorideContent determinationUncertainty
分類號:
R286
DOI:
10.3969/j.issn.1006-1959.2020.04.062
文獻標志碼:
A
摘要:
目的 建立高效液相色譜法(HPLC)測定鹽酸伊托必利片含量測量的不確定度評定方法。方法 通過建立高效液相色譜法測定鹽酸伊托必利片含量的數學模型,分析不確定度的來源,并對各個不確定度分量、合成不確定度進行評估,得出擴展不確定度。結果 高效液相色譜法測定鹽酸伊托必利片含量為99.70%,置信概率P為95.00%時,其擴展不確定度為3.59%,測定結果可以表示為(99.70±3.59)%,k=2。結論 該法可用于高效液相色譜法測定鹽酸伊托必利片含量的不確定度分析。
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.

參考文獻/References:

[1]中華人民共和國藥典委員會.中華人民共和國藥典臨床用藥須知(化學藥和生物制品卷)[S].2010年版.北京:中國醫藥科技出版社,383. [2]國家質量技術監督檢驗檢疫總局.JJF1135-2005化學分析測量不確定度評定[S].北京:中國計量出版社,2005. [3]國家質量監督檢驗檢疫總局.JJG196-2006 常用玻璃量器檢定規程[S].北京.中國計量出版社,2006. [4]EURACHEM\CITAC GUIDE.量化分析測量不確定度指南[M].北京:中國計量出版社,2003:129. [5]國家質量技術監督局.測量不確定度評定與表示(JJF1059-2012)[S].北京:中國計量出版社,2012.

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更新日期/Last Update: 2020-02-15
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