• Amandine Dispas
  • Roland Marini
  • Vincent Desfontaine
  • Jean-Luc Veuthey
  • Dorina Kotoni
  • Luca Gioacchino Losacco
  • Adrian Clarke
  • Brandon M Jocher
  • Erik L Regalado
  • Katerina Plachká
  • Benjamin Wuyts
  • Isabelle François
  • Michael Gray
  • Andrew J Aubin
  • Abhijit Tarafder
  • Maxime Cazes
  • Christophe Desvignes
  • Loic Villemet
  • Morgan Sarrut
  • Adrien Raimbault
  • Elise Lemasson
  • Eric Lesellier
  • Caroline West
  • Tomas Leek
  • Mengling Wong
  • Lulu Dai
  • Kelly Zhang
  • Alexandre Grand-Guillaume Perrenoud
  • Claudio Brunelli
  • Philippe Hennig
  • Sophie Bertin
  • Fabien Mauge
  • Nathalie Da Costa
  • William P Farrell
  • Madeleine Hill
  • Niranjan Desphande
  • Manish Grangrade
  • Santosh Sadaphule
  • Ravi Yadav
  • Sandesh Rane
  • Shankar Shringare
  • Marion Iguiniz
  • Sabine Heinisch
  • Julien Lefevre
  • Estelle Corbel
  • Nicolas Roques
  • Davy Guillarme
  • Philippe Hubert

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.

Original languageEnglish
Pages (from-to)414-424
Number of pages11
JournalJournal of Pharmaceutical and Biomedical Analysis
Early online date23 Aug 2018
Publication statusPublished - 30 Nov 2018

    Research areas

  • Collaborative study, Inter-laboratory study, Pharmaceutical impurities, Reproducibility, Salbutamol sulfate, Supercritical Fluid Chromatography (SFC)

ID: 39492650