Article (Scientific journals)
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
Habyalimana, Védaste; Mbinze Kindenge, Jérémie; Yemoa, Loconon et al.
2017In Journal of Pharmaceutical and Biomedical Analysis, 139, p. 8-21
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Keywords :
Optimization; Design of experiment - Design space; Antiretroviral medicines; Validation; Application
Abstract :
[en] tAs 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.
Research center :
Centre Interfacultaire de Recherche du Médicament - CIRM
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Habyalimana, Védaste ;  Université de Liège - ULiège > Doct. sc. bioméd. & pharma. (Bologne)
Mbinze Kindenge, Jérémie ;  Université de Liège - ULiège > chercheur libre médecine
Yemoa, Loconon ;  Université de Liège - ULiège > chercheur libre médecine
Waffo Tchounga, Christelle  
Diallo, Tidiane
Kalenda Tshilombo, Nicodème ;  Université de Liège - ULiège > Doct. sc. bioméd. & pharma. (Bologne)
Kadima Ntokamunda, Justin-Léonard
Lebrun, Pierre ;  Université de Liège > Département de pharmacie > Chimie analytique
Hubert, Philippe  ;  Université de Liège > Département de pharmacie > Chimie analytique
Marini Djang'Eing'A, Roland ;  Université de Liège > Département de pharmacie > Chimie analytique
Language :
English
Title :
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
Publication date :
February 2017
Journal title :
Journal of Pharmaceutical and Biomedical Analysis
ISSN :
0731-7085
eISSN :
1873-264X
Publisher :
Elsevier
Volume :
139
Pages :
8-21
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
CTB - Coopération Technique Belge [BE]
Available on ORBi :
since 24 March 2017

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