en
Scientific article
English

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

Published inJournal of Pharmaceutical and Biomedical Analysis, vol. 161, p. 414-424
Publication date2018
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
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. doi: 10.1016/j.jpba.2018.08.042
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ISSN of the journal0731-7085
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