Article (Scientific journals)
LC method for the determination of R-timolol in S-timolol maleate: Validation of its ability to quantify and uncertainty assessment.
Marini Djang'Eing'A, Roland; Chiap, Patrice; Boulanger, Bruno et al.
2006In Talanta, 68 (4), p. 1166-1175
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Keywords :
risk; validation; liquid chromatography; R-timolol impurity; timolol maleate; accuracy profile; uncertainty assessment
Abstract :
[en] This article presents the validation results of a chiral liquid chromatographic (LC) method previously developed for the quantitative determination of R-timolol in S-timolol maleate samples. A novel validation strategy based on the accuracy profiles was used to select the most appropriate regression model, to assess the method accuracy within well defined acceptance limits and to determine the limits of quantitation as well as the concentration range. The validation phase was completed by the investigation of the risk profiles of various acceptable regression models in order to ensure the risk of obtaining the future measurements outside the acceptance limits fixed a priori. On the other hand, the present paper also shows how data used in this validation approach can be used to estimate the measurement uncertainty. The uncertainty derived from beta-expectation tolerance interval (sigma(Tol)(2)), which is equal to the uncertainty of measurements as well as the expanded uncertainty (U(x)) using a coverage factor k=2 was estimated. The uncertainty estimates obtained from validation data were finally compared with those obtained from interlaboratory and robustness studies.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Marini Djang'Eing'A, Roland ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Chiap, Patrice ;  Centre Hospitalier Universitaire de Liège - CHU > Pharmacologie clinique
Boulanger, Bruno ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Rudaz, S.
Rozet, Eric ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Crommen, Jacques ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
LC method for the determination of R-timolol in S-timolol maleate: Validation of its ability to quantify and uncertainty assessment.
Publication date :
2006
Journal title :
Talanta
ISSN :
0039-9140
eISSN :
1873-3573
Publisher :
Elsevier Science Bv, Amsterdam, United Kingdom
Volume :
68
Issue :
4
Pages :
1166-1175
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 16 March 2009

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