Reference : Uncertainty assessment from robustness testing applied on an LC assay for R-timolol and ...
Scientific journals : Article
Physical, chemical, mathematical & earth Sciences : Chemistry
http://hdl.handle.net/2268/9014
Uncertainty assessment from robustness testing applied on an LC assay for R-timolol and other related substances in S-timolol maleate
English
Marini Djang'Eing'A, Roland mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Boulanger, Bruno [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Vanderheyden, Yvan [> >]
Chiap, Patrice mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Crommen, Jacques mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Hubert, Philippe mailto [Université de Liège - ULg > > Chimie analytique >]
21-Feb-2005
Analytica Chimica Acta
Elsevier Science Bv
531
1
131-140
Yes (verified by ORBi)
International
0003-2670
1873-4324
Amsterdam
The Netherlands
[en] robustness testing ; liquid chromatography (LC) ; timolol maleate ; quantitative responses ; uncertainty assessment
[en] The robustness testing of a normal-phase liquid chromatographic (LC) method for the determination of R-timolol and other related substances in S-timolol maleate was performed applying a two-level Plackett-Burman design. Two qualitative and five quantitative factors were examined. Two types of responses were considered, qualitative, i.e. chromatographic performance criteria, and quantitative ones. The latter were taken into account to determine if the analytical procedure was robust. The quantitative responses were the contents of R-timolol in two S-timolol maleate samples. Even though some significant factor effects were observed on the qualitative responses, the R-timolol contents were not significantly different from those observed at nominal conditions, which demonstrated the robustness of the procedure. Since the experiments of the Plackett-Burman design can be assimilated to laboratories in an interlaboratory study, uncertainty can be evaluated using the robustness test data. The robustness test was set-up in such a way that the required variances could be estimated. It was shown that the robustness set-up allows estimating the reproducibility uncertainty without performing an interlaboratory study. (c) 2004 Elsevier B.V. All rights reserved.
Belgian Government (The Prime Minister Services – Federal Office for Scientific, Technical and Cultural Affairs)
Standardization Program, No. NM/12/23
General public ; Professionals ; Researchers
http://hdl.handle.net/2268/9014
also: http://hdl.handle.net/2268/12816
10.1016/j.aca.2004.10.004

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