Reference : Application of design space optimization strategy to the developmentof LC methods for...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/208543
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
English
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, Christelle [> >]
Diallo, Tidiane [> >]
Kalenda Tshilombo, Nicodème [Université de Liège - ULiège > > > Doct. sc. bioméd. & pharma. (Bologne)]
Kadima Ntokamunda, Justin-Léonard [> >]
Lebrun, Pierre mailto [Université de Liège > Département de pharmacie > Chimie analytique >]
Hubert, Philippe mailto [Université de Liège > Département de pharmacie > Chimie analytique >]
Marini Djang'Eing'A, Roland mailto [Université de Liège > Département de pharmacie > Chimie analytique >]
Feb-2017
Journal of Pharmaceutical and Biomedical Analysis
Elsevier
139
8-21
Yes (verified by ORBi)
International
0731-7085
1873-264X
[en] Optimization ; Design of experiment - Design space ; Antiretroviral medicines ; Validation ; Application
[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.
Centre Interfacultaire de Recherche du Médicament - CIRM
Coopération technique belge - Université de Liège
Researchers ; Professionals ; Students ; General public
http://hdl.handle.net/2268/208543
10.1016/j.jpba.2017.02.040
http://dx.doi.org/10.1016/j.jpba.2017.02.040.

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