1. First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities
- Author
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Madeleine Hill, Philippe Hubert, Katerina Plachka, Abhijit Tarafder, Adrien Raimbault, Benjamin Wuyts, Manish Grangrade, Niranjan Desphande, Andrew J. Aubin, Fabien Mauge, Vincent Desfontaine, Lucie Nováková, Erik L. Regalado, Mengling Wong, Sophie Bertin, Alexandre Grand-Guillaume Perrenoud, Julien Lefevre, Estelle Corbel, Caroline West, Elise Lemasson, Santosh Sadaphule, Dorina Kotoni, Brandon M. Jocher, Adrian Clarke, Marion Iguiniz, Eric Lesellier, Tomas Leek, Davy Guillarme, Debby Mangelings, Yvan Vander Heyden, Loic Villemet, Ravi Yadav, Nicolas Roques, Sabine Heinisch, Philippe Hennig, Luca Gioacchino Losacco, Isabelle François, Maxime Cazes, Nathalie Da Costa, Claudio Brunelli, Jean-Luc Veuthey, William Farrell, Kelly Zhang, Roland Djang’eing’a Marini, Christophe Desvignes, Shankar Shringare, Charlene Galea, Michael J. Gray, Amandine Dispas, Sandesh Rane, Lulu Dai, Morgan Sarrut, School of Pharmaceutical Science, University of Geneva [Switzerland]-Université de Lausanne (UNIL), Laboratoire De Chimie Analytique Pharmaceutique, Université de Genève (UNIGE)-Ecole de pharmacie Genève-Lausanne (EPGL), Special Pathogens, Public Health Agency of Canada-National Microbiology Laboratory, Chromatography & Hyphenated Techniques - Chromatographie et techniques couplées, Institut des Sciences Analytiques (ISA), Institut de Chimie du CNRS (INC)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut de Chimie du CNRS (INC)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS), Sanofi R&D, Analyt Sci, Institut de Chimie Organique et Analytique (ICOA), Université d'Orléans (UO)-Centre National de la Recherche Scientifique (CNRS)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut de Chimie du CNRS (INC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Tampere University of Technology [Tampere] (TUT), NASA Goddard Space Flight Center (GSFC), Oril Industrie, Laboratoire des Sciences de l'Information et des Systèmes (LSIS), Centre National de la Recherche Scientifique (CNRS)-Arts et Métiers Paristech ENSAM Aix-en-Provence-Université de Toulon (UTLN)-Aix Marseille Université (AMU), Institut National de l'Environnement Industriel et des Risques (INERIS), Research grants from Walloon Region of Belgium and EU Commission (project FEDER-PHARE) to Amandine DISPAS are gratefully acknowledged. Waters (Milford, MA, USA) is acknowledged for supplying all columns used in this study. Novartis (Basel, Switzerland) is acknowledged for funding the EDQM standards sent to the participating laboratories. The author wants to thank M. Heptia and B. Dahmen for technical assistance and F. Bonivert for logistic help. K. Plachka and L. Novakova wish to gratefully acknowledge the grant project SVV No. 260412/2018 and the STARSS project (Reg. No. CZ.02.1.01/0.0/0.0/15_003/0000465) co-funded by ERDF. L. Montis (Waters) is acknowledged., Faculty of Medicine and Pharmacy, Pharmaceutical and Pharmacological Sciences, Chemical Engineering and Industrial Chemistry, Department of Analytical Chemistry, Applied Chemometrics and Molecular Modelling, Université de Lausanne = University of Lausanne (UNIL)-Université de Genève = University of Geneva (UNIGE), Université de Genève = University of Geneva (UNIGE)-Ecole de pharmacie Genève-Lausanne (EPGL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université d'Orléans (UO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), and Aix Marseille Université (AMU)-Université de Toulon (UTLN)-Arts et Métiers Paristech ENSAM Aix-en-Provence-Centre National de la Recherche Scientifique (CNRS)
- Subjects
Quality Control ,spectroscopy ,Salbutamol sulfate ,International Cooperation ,Transferability ,Clinical Biochemistry ,Pharmaceutical Science ,Context (language use) ,Food company ,01 natural sciences ,Analytical Chemistry ,[CHIM.ANAL]Chemical Sciences/Analytical chemistry ,Drug Discovery ,Supercritical Fluid Chromatography (SFC) ,Inter-laboratory ,Process engineering ,Pharmaceutical impurities ,Collaborative study ,ddc:615 ,Reproducibility ,010405 organic chemistry ,business.industry ,Chemistry ,010401 analytical chemistry ,Reproducibility of Results ,Chromatography, Supercritical Fluid ,Repeatability ,0104 chemical sciences ,Supercritical fluid chromatography ,Drug Contamination ,business ,Inter-laboratory study ,Chromatography, Liquid - Abstract
International audience; Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and transferability to various laboratories around the world. Therefore, an inter-laboratory study was conducted and published for the first time in SFC, to assess method reproducibility, and evaluate whether this chromatographic technique could become a reference method for quality control (QC) laboratories. This study involved 19 participating laboratories from 4 continents and 9 different countries. It included 5 academic groups, 3 demonstration laboratories at analytical instrument companies, 10 pharmaceutical companies and 1 food company. In the initial analysis of the study results, consistencies within- and between-laboratories were deeply examined. In the subsequent analysis, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. The results obtained were compared with the literature values for liquid chromatography (LC) in the context of impurities determination. Repeatability and reproducibility variances were found to be similar or better than 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, this complementary technique is recognized on equal merit to other chromatographic techniques.
- Published
- 2018