Article (Scientific journals)
Uncertainty assessment from robustness testing applied on an LC assay for R-timolol and other related substances in S-timolol maleate
Marini Djang'Eing'A, Roland; Boulanger, Bruno; Vanderheyden, Yvan et al.
2005In Analytica Chimica Acta, 531 (1), p. 131-140
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Keywords :
robustness testing; liquid chromatography (LC); timolol maleate; quantitative responses; uncertainty assessment
Abstract :
[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.
Disciplines :
Chemistry
Author, co-author :
Marini Djang'Eing'A, Roland ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Boulanger, Bruno ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Vanderheyden, Yvan
Chiap, Patrice ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Crommen, Jacques ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Hubert, Philippe  ;  Université de Liège - ULiège > Chimie analytique
Language :
English
Title :
Uncertainty assessment from robustness testing applied on an LC assay for R-timolol and other related substances in S-timolol maleate
Publication date :
21 February 2005
Journal title :
Analytica Chimica Acta
ISSN :
0003-2670
eISSN :
1873-4324
Publisher :
Elsevier Science Bv, Amsterdam, Netherlands
Volume :
531
Issue :
1
Pages :
131-140
Peer reviewed :
Peer Reviewed verified by ORBi
Name of the research project :
Standardization Program, No. NM/12/23
Funders :
Belgian Government (The Prime Minister Services – Federal Office for Scientific, Technical and Cultural Affairs)
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