Article (Scientific journals)
A New Method for Quality by Design Robust Optimization in Liquid Chromatography
Debrus, Benjamin; Lebrun, Pierre; Rozet, Eric et al.
2013In LC-GC Europe
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Abstract :
[en] A new method to optimize liquid chromatography (LC) methods using a Quality by Design (QbD) approach is presented. This method is based on the use of design of experiments (DOE) and independent component analysis (ICA) to accurately estimate the modelled responses (that is, the retention times at the beginning, the apex, and the end) of each peak, even for coeluted peaks. The modelling of these responses usesmultiple linear regressions, while the propagation of the error affecting the responses and coming from the models is carried out by Monte Carlo simulation. The design space is determined as the region of assay factors where the probability to reach baseline-resolved peaks is higher than the desired level of quality. This method was applied to the optimization of the separation of nine compounds in a mixture, yielding the design space and the demonstration of robustness of the method. Finally, the method was validated.
Research center :
Centre Interfacultaire de Recherche du Médicament - CIRM - Département de Pharmacie
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Debrus, Benjamin ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Lebrun, Pierre ;  Université de Liège - ULiège > HEC - École de gestion de l'ULiège > HEC-Ecole de gestion
Rozet, Eric ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Schofield, Tim
Mbinze Kindenge, Jérémie
Marini Djang'Eing'A, Roland ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Rudaz, Serge
Boulanger, Bruno ;  Université de Liège - ULiège > Département de pharmacie > Département de pharmacie
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
A New Method for Quality by Design Robust Optimization in Liquid Chromatography
Publication date :
July 2013
Journal title :
LC-GC Europe
ISSN :
1471-6577
eISSN :
2767-7095
Publisher :
Advanstar Communications Inc., Duluth, United States - Minnesota
Pages :
-
Peer reviewed :
Peer Reviewed verified by ORBi
Name of the research project :
-
Available on ORBi :
since 09 July 2013

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