Publications Scientifiques

[ Article ] Fighting Poor Quality Medicines: Development, Transfer and Validation of Generic HPLC Methods for Analyzing two WHO Recommended Antimalarial Tablets

Date de soumission: 01-03-2017
Année de Publication: 2015
Entité/Laboratoire Laboratoire de Chimie Analytique et Analyse des Médicaments ( LCAM)
Document type : Article
Discipline(s) : Chimie Analytique et Bromatologie
Titre Fighting Poor Quality Medicines: Development, Transfer and Validation of Generic HPLC Methods for Analyzing two WHO Recommended Antimalarial Tablets
Auteurs Kindenge Mbinze Jeremie [1], YEMOA Loconon Y. Achille [1], LEBRUN Pierre [2], Sacré Pierre-Yves [3], Habyalimana Védaste [4], Kalenda Nicodème [5], BIGOT KOFFI ANDRÉ [6], ATINDEHOU Eugène [7], Hubert Philippe [8], Djang’eing’a Marini Roland [9],
Journal: American Journal of Analytical Chemistry
Catégorie Journal: Internationale
Impact factor: 1.14
Volume Journal: 6
Resume 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 developed 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; 10 mM) (82.5:17.5, v/v) at 0.6 ml/min through a C18 column (100 mm × 3.5 mm, 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.
Mots clés Antimalarial, ACT, Simultaneous Determination, Poor Quality Substances, Design of Experiments, Design Space, Method Transfer, Accuracy Profile
Pages 127 - 144
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