An Overall Validation Approach Based on β-Content, γ-Confidence Tolerance Interval, and Uncertainty Profile: Application to LC-MS/MS Quantification of Carbendazim in Drinking Water.

IF 1.7 4区 农林科学 Q3 CHEMISTRY, ANALYTICAL
Hicham Aaziz, Taoufiq Saffaj, Nabil Saffaj, Rachid Mamouni, Bouchaib Ihssane
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引用次数: 0

Abstract

Background: Carbendazim is a fungicide which can seep into the water supply, presenting a public health risk, and therefore the accurate trace determination of this substance is very important.

Objective: The purpose of the study is to take a top-down analytical validation approach in order to determine the amount of carbendazim in drinking water by using an SPE-LC-MS/MS technique.

Methods: Quantification of carbendazim using solid-phase extraction coupled with LC-MS/MS was used in order to ensure the accuracy of the analytical method and to control the risk of its routine application. An overall validation methodology based on two-sided tolerance interval type β-content, γ-confidence has been applied for the validation and estimation of uncertainty by building a decision graphical tool called the "uncertainty profile" by using the statistical process known as the Satterthwaite approximation with no recourse to additional data by satisfying intermediate precision condition for each concentration level within the acceptance limits fixed in advance.

Results: The process of validation is based on the selection of a linear weighted 1/X model enabling validation of the carbendazim dosage using LC-MS/MS in the range of working concentrations as the βγ-CCTI fell inside acceptable limits of ±10%, and the relative expanded uncertainty did not surpass 7% regardless of the β values (66.7, 80, and 90%) and the 1- γ = risk (10 and 5%).

Conclusion: The application of the uncertainty profile approach for full validation of a SPE-LC-MS/MS assay for the quantification of carbendazim has been successfully achieved.

Highlights: Implementation of a full validation strategy based on validation and measurement uncertainty with no additional effort using data from analytical validation under intermediate precision conditions at each level of concentration for carbendazim quantification in drinking water using SPE-LC-MS/MS. So we have shown the flexibility of this approach for carbendazim assay by LC-MS/MS. Indeed, It provides an efficient decision-making tool that allows selection and modification of β-content and γ-confidence values.

基于β-含量、γ-置信容忍区间和不确定度曲线的整体验证方法在饮用水中多菌灵LC-MS/MS定量中的应用
背景:多菌灵是一种能渗入水源的杀菌剂,对公众健康构成威胁,因此对该物质的准确痕量测定具有重要意义。目的:采用自上而下的分析验证方法,采用SPE-LC-MS/MS技术测定饮用水中多菌灵的含量。方法:采用固相萃取联用LC-MS/MS对多菌灵进行定量分析,以保证分析方法的准确性,并控制其常规应用的风险。基于双侧容差区间型β-含量γ-置信度的总体验证方法应用于不确定度的验证和估计,采用Satterthwaite近似的统计过程,通过满足预先确定的可接受范围内各浓度水平的中间精度条件,建立了不确定度剖面决策图形工具。结果:验证过程基于选择线性加权1/X模型,当βγ- ccti在±10%的可接受范围内时,使用LC-MS/MS在工作浓度范围内验证多菌多胺剂量,无论β值(66.7,80和90%)和1- γ =风险(10和5%),相对扩展不确定度均不超过7%。结论:应用不确定度谱法对多菌灵的定量分析方法进行了充分验证。重点:在使用SPE-LC-MS/MS对饮用水中多菌灵进行定量分析时,在中等精密度条件下,使用来自分析验证的数据,在验证和测量不确定度的基础上,无需额外的努力,实现了完整的验证策略。因此,我们已经证明了这种方法的灵活性,多菌灵的LC-MS/MS分析。事实上,它提供了一个有效的决策工具,允许选择和修改β含量和γ置信度值。
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来源期刊
Journal of AOAC International
Journal of AOAC International 医学-分析化学
CiteScore
3.10
自引率
12.50%
发文量
144
审稿时长
2.7 months
期刊介绍: The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.
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