Article (Scientific journals)
Innovative high-performance liquid chromatography method development for the screening of 19 antimalarial drugs based on a generic approach, using design of experiments, independent component analysis and design space
Debrus, Benjamin; Lebrun, Pierre; Mbinze Kindenge, Jérémie et al.
2011In Journal of Chromatography. A, 1218, p. 5205-5215
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Keywords :
Antimalarial drugs; Counterfeit medecine; Design of experiments; Design space; Quality by design; Independent component analysis
Abstract :
[en] An innovative methodology based on design of experiments (DoE), independent component analysis (ICA) and design space (DS) was developed in previous works and was tested out with a mixture of 19 antimalarial drugs. This global LC method development methodology (i.e. DoE–ICA–DS) was used to optimize the separation of 19 antimalarial drugs to obtain a screening method. DoE–ICA–DS methodology is fully compliant with the current trend of quality by design. DoE was used to define the set of experiments to model the retention times at the beginning, the apex and the end of each peak. Furthermore, ICA was used to numerically separate coeluting peaks and estimate their unbiased retention times. Gradient time, temperature and pH were selected as the factors of a full factorial design. These retention times were modelled by stepwise multiple linear regressions. A recently introduced critical quality attribute, namely the separation criterion (S), was also used to assess the quality of separations rather than using the resolution. Furthermore, the resulting mathematical models were also studied from a chromatographic point of view to understand and investigate the chromatographic behaviour of each compound. Good adequacies were found between the mathematical models and the expected chromatographic behaviours predicted by chromatographic theory. Finally, focusing at quality risk management, the DS was computed as the multidimensional subspace where the probability for the separation criterion to lie in acceptance limits was higher than a defined quality level. The DS was computed propagating the prediction error from the modelled responses to the quality criterion using Monte Carlo simulations. DoE–ICA–DS allowed encountering optimal operating conditions to obtain a robust screening method for the 19 considered antimalarial drugs in the framework of the fight against counterfeit medicines. Moreover and only on the basis of the same data set, a dedicated method for the determination of three antimalarial compounds in a pharmaceutical formulation was optimized to demonstrate both the efficiency and flexibility of the methodology proposed in the present study.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Debrus, Benjamin ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Lebrun, Pierre ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Mbinze Kindenge, Jérémie
Lecomte, Frédéric  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Ceccato, Attilio ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Caliaro, Gabriel
Mavar Tayey Mbay, Jean
Boulanger, Bruno ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Marini Djang'Eing'A, Roland ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Rozet, Eric ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Innovative high-performance liquid chromatography method development for the screening of 19 antimalarial drugs based on a generic approach, using design of experiments, independent component analysis and design space
Publication date :
2011
Journal title :
Journal of Chromatography. A
ISSN :
0021-9673
eISSN :
1873-3778
Publisher :
Elsevier Science, Amsterdam, Netherlands
Volume :
1218
Pages :
5205-5215
Peer reviewed :
Peer Reviewed verified by ORBi
Name of the research project :
Optimal-DS
Funders :
DGTRE - Région wallonne. Direction générale des Technologies, de la Recherche et de l'Énergie [BE]
F.R.S.-FNRS - Fonds de la Recherche Scientifique [BE]
Arlenda SA
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