Publications Scientifiques

[ Article ] Application of design space optimization strategy to the developmentof LC methods for simultaneous analysis of 18 antiretroviral medicinesand 4 major excipients used in various pharmaceutical formulations

Date de soumission: 17-05-2017
Année de Publication: 2017
Entité/Laboratoire Laboratoire de Chimie Analytique et Analyse des Médicaments ( LCAM)
Document type : Article
Discipline(s) : Chimie Analytique et Bromatologie
Titre Application of design space optimization strategy to the developmentof LC methods for simultaneous analysis of 18 antiretroviral medicinesand 4 major excipients used in various pharmaceutical formulations
Auteurs Habyalimana Védaste [1], Kindenge Mbinze Jeremie [2], YEMOA Loconon Y. Achille [3], WAFFO Christelle [4], Kalenda Nicodème [5], Ntokamunda Justin-Léonard Kadima [6], LEBRUN Pierre [6], Hubert Philippe [6], Djang’eing’a Marini Roland [6],
Journal: Journal of Pharmaceutical and Biomedical Analysis
Catégorie Journal: Internationale
Impact factor: 3.169
Volume Journal: 139
DOI: 10.1016/j.jpba.2017.02.040.
Resume As one of the world’s most significant public health challenges in low- and middle-income countries,HIV/AIDS deserves to be treated with appropriate medicines, however which are not spared from coun-terfeiting. For that, we developed screening and specific HPLC methods that can analyze 18 antiretroviralmedicines (ARV) and 4 major excipients. Design of experiments and design space methodology wereinitially applied for 15 ARV and the 4 excipients with prediction thanks to Monte Carlo simulations andfocusing on rapidity and affordability thus using short column and low cost organic solvent (methanol)in gradient mode with 10 mM buffer solutions of ammonium hydrogen carbonate. Two other specificmethods dedicated to ARV in liquid and in solid dosage formulations were also predicted and opti-mized. We checked the ability of one method for the analysis of a fixed-dose combination composedby emtricitabine/tenofovir/efavirenz in tablet formulations. Satisfying validation results were obtainedby applying the total error approach taking into account the accuracy profile as decision tool. Then, thevalidated method was applied to test two samples coded A and B, and claimed to contain the tested ARV.Assay results were satisfying only for sample B.
Mots clés Optimization-Design of experiment – design space-Antiretroviral medicines-Validation-Application
Pages 8 - 21
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