First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu srovnávací studie, časopisecké články
PubMed
30216790
DOI
10.1016/j.jpba.2018.08.042
PII: S0731-7085(18)31547-4
Knihovny.cz E-zdroje
- Klíčová slova
- Collaborative study, Inter-laboratory study, Pharmaceutical impurities, Reproducibility, Salbutamol sulfate, Supercritical Fluid Chromatography (SFC),
- MeSH
- chromatografie kapalinová metody normy MeSH
- kontaminace léku prevence a kontrola MeSH
- mezinárodní spolupráce * MeSH
- reprodukovatelnost výsledků MeSH
- řízení kvality MeSH
- superkritická fluidní chromatografie metody normy MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
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.
Cipla R and D centre Analytical development lab LBS Road Vikhroli Mumbai 400083 India
Merck and Co Inc Process Research and Development MRL Rahway NJ 07065 USA
Novartis Pharma AG Technical R and D Chemical and Analytical Development Basel CH4056 Switzerland
Oril Industries 13 rue Auguste Desgenetais 76210 Bolbec France
Pfizer Global R and D Analytical R and D Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Sanofi R and D Analytical Sciences 13 Quai Jules Guesde 94400 Vitry sur Seine France
Sanofi R and D Analytical Sciences 371 Rue du Professeur Blayac 34080 Montpellier France
SERVIER Research Institute Analytical and Physical Chemistry Department France
University of Orléans ICOA CNRS UMR 7311 rue de Chartres BP 6759 45067 Orléans Cedex 2 France
Vrije Universiteit Brussel Laarbeeklaan 103 1090 Brussels Belgium
Waters Australia PTY LTD Australia
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