title: Evaluation of the quantitative performances of supercritical fluid chromatography: from method development to validation.
abstract: Recently, the number of papers about SFC increased drastically but scientists did not truly focus their work on quantitative performances of this technique. In order to prove the potential of UHPSFC, the present work discussed about the different steps of the analytical life cycle of a method: from development to validation and application. Moreover, the UHPSFC quantitative performances were evaluated in comparison with UHPLC, which is the main technique used for quality control in the pharmaceutical industry and then could be considered as a reference. The methods were developed using Design Space strategy, leading to the optimization of robust method. In this context, when the Design Space optimization shows guarantee of quality, no more robustness study is required prior to the validation. Then, the methods were geometrically transferred in order to reduce the analysis time. The UHPSFC and UHPLC methods were validated based on the total error approach using accuracy profile. Even if UHPLC showed better precision and sensitivity, UHPSFC method is able to give accurate results in a dosing range larger than the 80-120% range required by the European Medicines Agency. Consequently, UHPSFC results are valid and could be used for the control of active substance in a finished pharmaceutical product. Finally, UHPSFC validated method was used to analyse real samples and gave similar results than the reference method (UHPLC).
authors: University of Liege (ULg), CIRM, Laboratory of Analytical Chemistry, 1 Avenue de l'Hôpital, B36, B-4000 Liège, Belgium. Electronic address: amandine.dispas@ulg.ac.be.
authors: Amandine
authors: A
authors: Dispas
authors: University of Liege (ULg), CIRM, Laboratory of Analytical Chemistry, 1 Avenue de l'Hôpital, B36, B-4000 Liège, Belgium; Arlenda s.a., Liège, Belgium.
authors: Pierre
authors: P
authors: Lebrun
authors: University of Liege (ULg), CIRM, Laboratory of Analytical Chemistry, 1 Avenue de l'Hôpital, B36, B-4000 Liège, Belgium.
authors: Eric
authors: E
authors: Ziemons
authors: University of Liege (ULg), CIRM, Laboratory of Analytical Chemistry, 1 Avenue de l'Hôpital, B36, B-4000 Liège, Belgium.
authors: Roland
authors: R
authors: Marini
authors: University of Liege (ULg), CIRM, Laboratory of Analytical Chemistry, 1 Avenue de l'Hôpital, B36, B-4000 Liège, Belgium; Arlenda s.a., Liège, Belgium.
authors: Eric
authors: E
authors: Rozet
authors: University of Liege (ULg), CIRM, Laboratory of Analytical Chemistry, 1 Avenue de l'Hôpital, B36, B-4000 Liège, Belgium.
authors: Philippe
authors: P
authors: Hubert
mesh_terms: D025924:Chromatography, Supercritical Fluid / Q000379:methods*; D011336:Probability; D012984:Software
keywords: Method validation; Quantitative performances; Supercritical fluid chromatography (SFC); Total error approach; Ultra high performance liquid chromatography (UHPLC); Ultra high performance supercritical fluid chromatography (UHPSFC)