Reference : LC method for the determination of R-timolol in S-timolol maleate: Validation of its abi...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/18790
LC method for the determination of R-timolol in S-timolol maleate: Validation of its ability to quantify and uncertainty assessment
English
Marini Djang'Eing'A, Roland mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Chiap, Patrice mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Boulanger, Bruno [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Rudaz, S. [> > > >]
Rozet, Eric mailto [Université de Liège - ULg > > Chimie analytique >]
Crommen, Jacques mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Hubert, Philippe mailto [Université de Liège - ULg > > Chimie analytique >]
15-Feb-2006
Talanta
Elsevier Science Bv
68
4
1166-1175
Yes (verified by ORBi)
International
0039-9140
Amsterdam
[en] timolol maleate ; R-timolol impurity ; liquid chromatography ; validation ; accuracy profile ; risk ; uncertainty assessment
[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-timoloi 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 P-expectation tolerance interval (sigma-(2)(Tol)), 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. (c) 2005 Elsevier B.V. All rights reserved.
http://hdl.handle.net/2268/18790

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