Article (Scientific journals)
Optimisation and validation of a fast HPLC method for the quantification of sulindac and its related impurities
Krier, Fabrice; Brion, Michaël; Debrus, Benjamin et al.
2011In Journal of Pharmaceutical and Biomedical Analysis, 54, p. 694-700
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Keywords :
HPLC; Sulindac; Validation; Design space; Optimisation; sub-2micron column
Abstract :
[en] The European Pharmacopoeia describes a liquid chromatography (LC) method for the quantification of sulindac, using a quaternary mobile phase including chloroform and with a rather long run time. In the present study, a new method using a short sub-2μm column, which can be used on a classical HPLC system, was developed. The new LC conditions (without chloroform) were optimised by means of a new methodology based on design of experiments in order to obtain an optimal separation. Four factors were studied: the duration of the initial isocratic step, the percentage of organic modifier at the beginning of the gradient, the percentage of organic modifier at the end of the gradient and the gradient time. The optimal condition allows the separation of sulindac and of its 3 related impurities in six minutes instead of 18 min. Finally, the method was successfully validated using an accuracy profile approach in order to demonstrate its ability to accurately quantify these compounds.
Research center :
C.I.R.M.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Krier, Fabrice ;  Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Brion, Michaël
Debrus, Benjamin ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Lebrun, Pierre ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Driesen, Aurélie
Ziemons, Eric  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Evrard, Brigitte  ;  Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Optimisation and validation of a fast HPLC method for the quantification of sulindac and its related impurities
Publication date :
2011
Journal title :
Journal of Pharmaceutical and Biomedical Analysis
ISSN :
0731-7085
eISSN :
1873-264X
Publisher :
Elsevier Science, Oxford, United Kingdom
Volume :
54
Pages :
694-700
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
DGTRE - Région wallonne. Direction générale des Technologies, de la Recherche et de l'Énergie [BE]
Available on ORBi :
since 08 November 2010

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