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Interlaboratory study of a supercritical fluid chromatography method for the determination of pharmaceutical impurities: Evaluation of multi-systems reproducibility.
Dispas, Amandine; Clarke, Adrian; Grand-Guillaume Perrenoud, Alexandre; Losacco, Luca Gioacchino; Veuthey, Jean-Luc; Gros, Quentin; Molineau, Jérémy; Noireau, Angéline; West, Caroline; Salafia, Fabio; Zoccali, Mariosimone; Mondello, Luigi; Guillen, Amber; Wang, Jenny; Zhang, Kelly; Jochems, Philipp; Schad, Gesa; Nakajima, Kosuke; Horie, Shinnosuke; Joseph, Jan; Parr, Maria Kristina; Billemont, Pierre; Severino, Antoni; Schneider, Sonja; Naegele, Edgar; Kutscher, Daniel; Wikfors, Rick; Black, Regina; Ingvaldson, Lee; Da Silva, Jimmy Oliveira; Bennett, Raffeal; Regalado, Erik L; Hoang, Thi Phuong Thuy; Touboul, David; Nikolova, Yana; Kamenova-Nacheva, Mariana; Dimitrov, Vladimir; Berger, Blair K; Schug, Kevin A; Kerviel-Guillon, Solène; Mauge, Fabien; Takahashi, Masatomo; Izumi, Yoshihiro; Bamba, Takeshi; Rouvière, Florent; Heinisch, Sabine; Guillarme, Davy; Hubert, Philippe.
Afiliación
  • Dispas A; University of Liège (ULiege), CIRM, Laboratory of Pharmaceutical Analytical Chemistry, CHU, Avenue Hippocrate 15, 4000 Liège, Belgium; University of Liège (ULiege), CIRM, Laboratory for the Analysis of Medicines, CHU, Avenue Hippocrate 15, 4000 Liège, Belgium. Electronic address: amandine.dispas@uli
  • Clarke A; Novartis Pharma AG, Technical R&D, Chemical and Analytical Development, Basel CH4056, Switzerland.
  • Grand-Guillaume Perrenoud A; Novartis Pharma AG, Technical R&D, Chemical and Analytical Development, Basel CH4056, Switzerland.
  • Losacco LG; School of Pharmaceutical Sciences, University of Geneva, CMU - Rue Michel-Servet 1, 1211 Geneva 4, Switzerland; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, CMU - Rue Michel-Servet 1, 1211 Geneva 4, Switzerland.
  • Veuthey JL; School of Pharmaceutical Sciences, University of Geneva, CMU - Rue Michel-Servet 1, 1211 Geneva 4, Switzerland; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, CMU - Rue Michel-Servet 1, 1211 Geneva 4, Switzerland.
  • Gros Q; University of Orléans, ICOA, CNRS UMR 7311, rue de Chartres, BP 6759, 45067 Orléans cedex 2, France.
  • Molineau J; University of Orléans, ICOA, CNRS UMR 7311, rue de Chartres, BP 6759, 45067 Orléans cedex 2, France.
  • Noireau A; University of Orléans, ICOA, CNRS UMR 7311, rue de Chartres, BP 6759, 45067 Orléans cedex 2, France.
  • West C; University of Orléans, ICOA, CNRS UMR 7311, rue de Chartres, BP 6759, 45067 Orléans cedex 2, France.
  • Salafia F; Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Messina, Italy.
  • Zoccali M; Department of Mathematical and Computer Science, Physical Sciences and Earth Sciences, University of Messina, Messina, Italy.
  • Mondello L; Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Messina, Italy; Chromaleont s.r.l., c/o Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Messina, Italy; BeSep s.r.l., c/o Department of Chemical
  • Guillen A; Genentech, USA.
  • Wang J; Genentech, USA.
  • Zhang K; Genentech, USA.
  • Jochems P; Shimadzu GmbH, Germany.
  • Schad G; Shimadzu GmbH, Germany.
  • Nakajima K; Shimadzu Corporation, Japan.
  • Horie S; Shimadzu Corporation, Japan.
  • Joseph J; University of Berlin, Germany.
  • Parr MK; University of Berlin, Germany.
  • Billemont P; UCB Pharma, Belgium.
  • Severino A; UCB Pharma, Belgium.
  • Schneider S; Agilent, Germany.
  • Naegele E; Agilent, Germany.
  • Kutscher D; Agilent, Germany.
  • Wikfors R; Agilent, USA.
  • Black R; Agilent, USA.
  • Ingvaldson L; Analytical Research and Development, MRL, Merck & Co, Inc., 126 E. Lincoln Ave, Rahway, NJ 07065, United States.
  • Da Silva JO; Analytical Research and Development, MRL, Merck & Co, Inc., 126 E. Lincoln Ave, Rahway, NJ 07065, United States.
  • Bennett R; Analytical Research and Development, MRL, Merck & Co, Inc., 126 E. Lincoln Ave, Rahway, NJ 07065, United States.
  • Regalado EL; Analytical Research and Development, MRL, Merck & Co, Inc., 126 E. Lincoln Ave, Rahway, NJ 07065, United States.
  • Hoang TPT; Université Paris-Saclay, CNRS, Institut de Chimie des Substances Naturelles, UPR 2301, 91198 Gif-sur-Yvette, France.
  • Touboul D; Université Paris-Saclay, CNRS, Institut de Chimie des Substances Naturelles, UPR 2301, 91198 Gif-sur-Yvette, France.
  • Nikolova Y; Sofia Tech Park, Laboratory For Extraction Of Natural Products And Synthesis Of Bioactive Compounds, Bulgaria.
  • Kamenova-Nacheva M; Sofia Tech Park, Laboratory For Extraction Of Natural Products And Synthesis Of Bioactive Compounds, Bulgaria.
  • Dimitrov V; Sofia Tech Park, Laboratory For Extraction Of Natural Products And Synthesis Of Bioactive Compounds, Bulgaria.
  • Berger BK; Department of Chemistry & Biochemistry, The University of Texas Arlington, Arlington, TX 76019-0065, USA.
  • Schug KA; Department of Chemistry & Biochemistry, The University of Texas Arlington, Arlington, TX 76019-0065, USA.
  • Kerviel-Guillon S; SERVIER Research Institute, Analytical and Physical Chemistry Department, France.
  • Mauge F; SERVIER Research Institute, Analytical and Physical Chemistry Department, France.
  • Takahashi M; Division of Metabolomics, Medical Institute of Bioregulation, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan.
  • Izumi Y; Division of Metabolomics, Medical Institute of Bioregulation, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan.
  • Bamba T; Division of Metabolomics, Medical Institute of Bioregulation, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan.
  • Rouvière F; Université de Lyon, Institut des Sciences Analytiques, UMR 5280, CNRS, Université Lyon 1, ENS Lyon, 5 rue de la Doua, 69100 Villeurbanne, France.
  • Heinisch S; Université de Lyon, Institut des Sciences Analytiques, UMR 5280, CNRS, Université Lyon 1, ENS Lyon, 5 rue de la Doua, 69100 Villeurbanne, France.
  • Guillarme D; School of Pharmaceutical Sciences, University of Geneva, CMU - Rue Michel-Servet 1, 1211 Geneva 4, Switzerland; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, CMU - Rue Michel-Servet 1, 1211 Geneva 4, Switzerland.
  • Hubert P; University of Liège (ULiege), CIRM, Laboratory of Pharmaceutical Analytical Chemistry, CHU, Avenue Hippocrate 15, 4000 Liège, Belgium.
J Pharm Biomed Anal ; 203: 114206, 2021 Sep 05.
Article en En | MEDLINE | ID: mdl-34146950
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Preparaciones Farmacéuticas / Cromatografía con Fluido Supercrítico Idioma: En Revista: J Pharm Biomed Anal Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Preparaciones Farmacéuticas / Cromatografía con Fluido Supercrítico Idioma: En Revista: J Pharm Biomed Anal Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido