Interlaboratory study of a supercritical fluid chromatography method for the determination of pharmaceutical impurities: Evaluation of multi-systems reproducibility

Autor: Jimmy Oliveira Da Silva, Mariana Kamenova-Nacheva, Jean-Luc Veuthey, Erik L. Regalado, Jérémy Molineau, Luigi Mondello, Lee Ingvaldson, Angéline Noireau, Kevin A. Schug, Mariosimone Zoccali, Jan Felix Joseph, David Touboul, Adrian Clarke, Quentin Gros, Thi Phuong Thuy Hoang, Davy Guillarme, Fabio Salafia, Maria Kristina Parr, Solène Kerviel-Guillon, Kosuke Nakajima, Florent Rouvière, Antoni Severino, Fabien Mauge, Shinnosuke Horie, Rick Wikfors, Takeshi Bamba, Gesa Schad, Vladimir Dimitrov, Regina Black, Caroline West, Luca Gioacchino Losacco, Sonja Schneider, Philipp Jochems, Daniel Kutscher, Edgar Naegele, Yana Nikolova, Amandine Dispas, Philippe Hubert, Yoshihiro Izumi, Masatomo Takahashi, Alexandre Grand-Guillaume Perrenoud, Sabine Heinisch, Raffeal Bennett, Pierre Billemont, Blair K. Berger, Kelly Zhang, Jenny Wang, Amber Guillen
Přispěvatelé: Institut de Chimie des Substances Naturelles (ICSN), Institut de Chimie du CNRS (INC)-Université Paris-Saclay-Centre National de la Recherche Scientifique (CNRS), 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), 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)
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Quality Control
Salbutamol sulfate
Instrumentation
Clinical Biochemistry
Transferability
Pharmaceutical Science
01 natural sciences
Analytical Chemistry
[CHIM.ANAL]Chemical Sciences/Analytical chemistry
Drug Discovery
Multi-instruments collaborative study
Pharmaceutical impurities
Process engineering
Spectroscopy
ComputingMilieux_MISCELLANEOUS
Protocol (science)
ddc:615
Reproducibility
010405 organic chemistry
business.industry
Chemistry
010401 analytical chemistry
Single type
Reproducibility of Results
Chromatography
Supercritical Fluid
Repeatability
Variance (accounting)
Supercritical fluid chromatography(SFC
0104 chemical sciences
[CHIM.THEO]Chemical Sciences/Theoretical and/or physical chemistry
Inter-laboratory study
Supercritical fluid chromatography (SFC)
Pharmaceutical Preparations
Supercritical fluid chromatography
[SDV.TOX.ECO]Life Sciences [q-bio]/Toxicology/Ecotoxicology
[SDE.BE]Environmental Sciences/Biodiversity and Ecology
business
[CHIM.OTHE]Chemical Sciences/Other
[CHIM.CHEM]Chemical Sciences/Cheminformatics
Zdroj: Journal of Pharmaceutical and Biomedical Analysis
Journal of Pharmaceutical and Biomedical Analysis, Elsevier, 2021, 203, pp.114206. ⟨10.1016/j.jpba.2021.114206⟩
Journal of Pharmaceutical and Biomedical Analysis, Vol. 203 (2021) P. 114206
ISSN: 0731-7085
DOI: 10.1016/j.jpba.2021.114206⟩
Popis: Modern supercritical fluid chromatography (SFC) is now a well-established technique, especially in the field of pharmaceutical analysis. We recently demonstrated the transferability and the reproducibility of a SFC-UV method for pharmaceutical impurities by means of an inter-laboratory study. However, as this study involved only one brand of SFC instrumentation (Waters®), the present study extends the purpose to multi-instrumentation evaluation. Specifically, three instrument types, namely Agilent®, Shimadzu®, and Waters®, were included through 21 laboratories (n = 7 for each instrument). First, method transfer was performed to assess the separation quality and to set up the specific instrument parameters of Agilent® and Shimadzu® instruments. Second, the inter-laboratory study was performed following a protocol defined by the sending lab. Analytical results were examined regarding consistencies within- and between-laboratories criteria. Afterwards, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. Reproducibility variance was larger than that observed during the first study involving only one single type of instrumentation. Indeed, we clearly observed an 'instrument type' effect. Moreover, the reproducibility variance was larger when considering all instruments than each type separately which can be attributed to the variability induced by the instrument configuration. Nevertheless, repeatability and reproducibility variances were found to be similar than those described for LC methods; i.e. reproducibility as %RSD was around 15 %. These results highlighted the robustness and the power of modern analytical SFC technologies to deliver accurate results for pharmaceutical quality control analysis.
Databáze: OpenAIRE
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