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Determination of uncertainty in analytical measurements from collaborative study results on the analysis of a phenoxymethylpenicillin sample |
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| Authors: | P Dehouck J Smeyers-Verbeke J Crommen R.D Marini G Decristoforo J De Beer C Stella O Estevenon E Roets |
| Affiliation: | a Laboratorium voor Farmaceutische Chemie en Analyse van Geneesmiddelen, Faculteit Farmaceutische Wetenschappen, Katholieke Universiteit Leuven, Van Evenstraat 4, 3000 Leuven, Belgium b Pharmaceutical and Biomedical Analysis, VUB, Brussels, Belgium c Department of Analytical Pharmaceutical Chemistry, Institute of Pharmacy, University of Liège, Liège, Belgium d Wetenschappelijk Instituut van de Nederlandse Apothekers, The Hague, The Netherlands e Quality Control Laboratories—Industrial Products—Betalactams, NOVARTIS Generics, Kundl, Austria f Wetenschappelijk Instituut voor Volksgezondheid—Louis Pasteur, Brussels, Belgium g Laboratory Analisi Farmaceutica, University “La Sapienza”, Rome, Italy h Laboratoire de Chimie Analytique Pharmaceutique, University Geneva, Geneva, Switzerland i Laboratoire de Chimie Analytique, Université Henri Poincaré, Nancy, France |
| Abstract: | The correct interpretation of a measurement result requires knowledge about its uncertainty. Depending on the conditions under which the analyst is operating, different operational definitions of uncertainty have been proposed. They include: within-laboratory uncertainty, reproducibility uncertainty, bias-included uncertainty and absolute uncertainty. Here we consider the evaluation of the reproducibility uncertainty derived from the results obtained in an inter-laboratory experiment. Nine laboratories participated in an inter-laboratory study for the analysis of phenoxymethylpenicillin. The analyses consisted of a Karl-Fischer water determination, an acid-base titration to assay phenoxymethylpenicillin and a liquid chromatography (LC) method to determine 4-hydroxyphenoxymethylpenicillin and other impurities. The experimental set-up allowed to obtain for each determination sr2 and sL2 as estimates of the repeatability variance (σr2) and the between-laboratory variance (σL2), respectively. The reproducibility uncertainties for the different assays were then derived from these estimates. |
| Keywords: | Uncertainty Collaborative study Reproducibility Phenoxymethylpenicillin |
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