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Title

First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities

Authors
Dispas, Amandine
Marini, Roland
Kotoni, Dorina
Losacco, Luca Gioacchino
Clarke, Adrian
Muscat Galea, Charlene
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Published in Journal of Pharmaceutical and Biomedical Analysis. 2018, vol. 161, p. 414-424
Abstract This study involved 19 participating laboratories from 4 continents and 9 different countries. It included5 academic groups, 3 demonstration laboratories at analytical instrument companies, 10 pharmaceuticalcompanies and 1 food company. In the initial analysis of the study results, consistencies within- andbetween-laboratories were deeply examined. In the subsequent analysis, the method reproducibilitywas estimated taking into account variances in replicates, between-days and between-laboratories. Theresults obtained were compared with the literature values for liquid chromatography (LC) in the contextof impurities determination. Repeatability and reproducibility variances were found to be similar or betterthan those described for LC methods, and highlighted the adequacy of the SFC method for QC analyses.The results demonstrated the excellent and robust quantitative performance of SFC. Consequently, thiscomplementary technique is recognized on equal merit to other chromatographic techniques.
Keywords Supercritical Fluid Chromatography (SFC)Inter-laboratory studyCollaborative studyReproducibilityPharmaceutical impuritiesSalbutamol sulfate
Identifiers
PMID: 30216790
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Structures
Research group Sciences analytiques
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DISPAS, Amandine et al. First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities. In: Journal of Pharmaceutical and Biomedical Analysis, 2018, vol. 161, p. 414-424. https://archive-ouverte.unige.ch/unige:113094

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Deposited on : 2019-01-21

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