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

Dispas, Amandine; Marini, Roland; Desfontaine, Vincent; Veuthey, Jean-Luc; Kotoni, Dorina; Losacco, Luca Gioacchino; Clarke, Adrian; Muscat Galea, Charlene; Mangelings, Debby; Jocher, Brandon M.; Regalado, Erik L.; Plachká, Katerina; Nováková, Lucie; Wuyts, Benjamin; François, Isabelle; Gray, Michael; Aubin, Andrew J.; Tarafder, Abhijit; Cazes, Maxime; Desvignes, Christophe; Villemet, Loic; Sarrut, Morgan; Raimbault, Adrien; Lemasson, Elise; Lesellier, Eric; West, Caroline; Leek, Tomas; Wong, Mengling; Dai, Lulu; Zhang, Kelly; Grand-Guillaume Perrenoud, Alexandre; Brunelli, Claudio; Hennig, Philippe; Bertin, Sophie; Mauge, Fabien; Da Costa, Nathalie; Farrell, William P.; Hill, Madeleine; Desphande, Niranjan; Grangrade, Manish; Sadaphule, Santosh; Yadav, Ravi; Rane, Sandesh; Shringare, Shankar; Iguiniz, Marion; Heinisch, Sabine; Lefevre, Julien; Corbel, Estelle; Roques, Nicolas; Heyden, Yvan Vander; Guillarme, Davy; Hubert, Philippe

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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 Desfontaine, Vincent Veuthey, Jean-Luc Kotoni, Dorina Losacco, Luca Gioacchino Clarke, Adrian Muscat Galea, Charlene Mangelings, Debby Jocher, Brandon M. Regalado, Erik L. Plachká, Katerina Nováková, Lucie Wuyts, Benjamin François, Isabelle Gray, Michael Aubin, Andrew J. Tarafder, Abhijit Cazes, Maxime Desvignes, Christophe Villemet, Loic Sarrut, Morgan Raimbault, Adrien Lemasson, Elise Lesellier, Eric West, Caroline Leek, Tomas Wong, Mengling Dai, Lulu Zhang, Kelly Grand-Guillaume Perrenoud, Alexandre Brunelli, Claudio Hennig, Philippe Bertin, Sophie Mauge, Fabien Da Costa, Nathalie Farrell, William P. Hill, Madeleine Desphande, Niranjan Grangrade, Manish Sadaphule, Santosh Yadav, Ravi Rane, Sandesh Shringare, Shankar Iguiniz, Marion Heinisch, Sabine Lefevre, Julien Corbel, Estelle Roques, Nicolas Heyden, Yvan Vander Guillarme, Davy Hubert, Philippe show all authors [1 - 52]
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 study — Collaborative study — Reproducibility — Pharmaceutical impurities — Salbutamol sulfate
Identifiers		DOI: 10.1016/j.jpba.2018.08.042 PMID: 30216790
Full text		Article (Published version) (759 Kb) - Limited access to UNIGE Other version: https://linkinghub.elsevier.com/retrieve/pii/S0731708518315474
Structures		Faculté des sciences / Section des sciences pharmaceutiques
Research group		Sciences analytiques
Citation (ISO format)		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