Article (Scientific journals)
Fighting Poor Quality Medicines: Develop-ment, Transfer and Validation of Generic HPLC Methods for Analyzing two WHO Recommended Antimalarial Tablets
Mbinze Kindenge, Jérémie; Yemoa, Achille; Lebrun, Pierre et al.
2015In American Journal of Analytical Chemistry, 6, p. 127-144
Peer reviewed
 

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Keywords :
Antimalarial; ACT; Simultaneous determination; Poor quality substances; Design of Experiments; Design Space; Method transfer; Accuracy profile
Abstract :
[en] As serious but neglected public health problems, poor quality medicines, i.e. for antimalarial medicines, urged to be fought. One of the approaches is to consider the analytical chemistry and separative techniques. In this study, a generic liquid chromatographic method was firstly devel-oped for the purpose of screening 8 antimalarial active ingredients, namely amodiaquine (AQ), piperaquine (PPQ), sulfalene (SL), pyrimethamine (PM), lumefantrine (LF), artesunate (AS), artemether (AM) and dihydroartemisinine (DHA) by applying DoE/DS optimization strategy. Since the method was not totally satisfying in terms of peak separation, further experiments were undergone applying the same development strategy while splitting the 8 ingredients into five groups. Excellent prediction was observed prior to correlation between retention times of predicted and observed separation conditions. Then, a successful geometric transfer was realized to reduce the analysis time focusing on the simultaneous quantification of two WHO's recommended ACTs in anti-malarial fixed-dose combination (AM-LF and AS-AQ) in tablets. The optimal separation was achieved using an isocratic elution of methanol-ammonium formate buffer (pH 2.8; 10mM) (82.5: 17.5, v/v) at 0.6ml/min through a C18 column (100mm×3.5mm, 3.5 μm) thermostated at 25°C. After a successful validation stage based on the total error approach, the method was applied to determine the content of AM/LF or AS/AQ in seven brands of antimalarial tablets currently marketed in West, Central and East Africa. Satisfying results were obtained compared to the claimed contents.
Research center :
Centre Interfacultaire de Recherche du Médicament - CIRM
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Mbinze Kindenge, Jérémie ;  Université de Liège - ULiège
Yemoa, Achille;  Université de Liège - ULiège
Lebrun, Pierre ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Sacre, Pierre-Yves  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Habyalimana, Védaste ;  Université de Liège - ULiège
Kalenda Tshilombo, Nicodème ;  Université de Liège - ULiège
Bigot, André;  Université d’Abomey Calavi - Bénin
Atindehou, Eugène;  Université Félix Houphouet Boigny - Côte d'Ivoire
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Marini Djang'Eing'A, Roland ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Fighting Poor Quality Medicines: Develop-ment, Transfer and Validation of Generic HPLC Methods for Analyzing two WHO Recommended Antimalarial Tablets
Publication date :
19 January 2015
Journal title :
American Journal of Analytical Chemistry
ISSN :
2156-8251
eISSN :
2156-8278
Publisher :
Scientific Research Publishing, Irvine, United States - California
Volume :
6
Pages :
127-144
Peer reviewed :
Peer reviewed
Name of the research project :
CONTRIBUTION A L’AMELIORATION ET AU DEVELOPPEMENT DE LA QUALITE DES MEDICAMENTS TRADITIONNELS ET MODERNES EN R.D. CONGO
Funders :
ARES CCD - Académie de Recherche et d'Enseignement Supérieur. Coopération au Développement [BE]
Available on ORBi :
since 20 January 2015

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