Reference : Interlaboratory study of a NACE method for the determination of R-timolol content in ...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/9012
Interlaboratory study of a NACE method for the determination of R-timolol content in S-timolol maleate: assessment of uncertainty.
English
Marini Djang'Eing'A, Roland mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Groom, Carl [> > > >]
Doucet, Francois R [> > > >]
Hawari, Jalal [> > > >]
Bitar, Yaser [> > > >]
Holzgrabe, Ulrike [> > > >]
Gotti, Roberto [> > > >]
Schappler, Julie [> > > >]
Rudaz, Serge [> > > >]
Veuthey, Jean-Luc [> > > >]
Mol, Roelof [> > > >]
Somsen, Govert W [> > > >]
de Jong, Gerhardus J [> > > >]
Ha, Pham Thi Thanh [> > > >]
Zhang, Jie [> > > >]
Van Schepdael, Ann [> > > >]
Hoogmartens, Jos [> > > >]
Brione, Willy [> > > >]
Ceccato, Attilio mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Boulanger, Bruno [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Mangelings, Debby [> > > >]
Vander Heyden, Yvan [> > > >]
Van Ael, Willy [> > > >]
Jimidar, Ilias [> > > >]
Pedrini, Matteo [> > > >]
Servais, Anne-Catherine mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Fillet, Marianne mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Crommen, Jacques mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Rozet, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Hubert, Philippe mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
2006
Electrophoresis
Vch Publishers
27
12
2386-99
Yes (verified by ORBi)
International
0173-0835
Weinheim
Germany
[en] Adrenergic beta-Antagonists/analysis ; Drug Contamination ; Electrophoresis, Capillary/methods ; Reproducibility of Results ; Technology Transfer ; Timolol/analysis ; Uncertainty
[en] Analyses of statistical variance were applied to evaluate the precision and practicality of a CD-based NACE assay for R-timolol after enantiomeric separation of R- and S-timolol. Data were collected in an interlaboratory study by 11 participating laboratories located in Europe and North America. General qualitative method performance was examined using suitability descriptors (i.e. resolution, selectivity, migration times and S/N), while precision was determined by quantification of variances in the determination of R-timolol at four different impurity levels in S-timolol maleate samples. The interlaboratory trials were designed in accordance with the ISO guideline 5725-2. This allowed estimating for each sample, the different variances, i.e. between-laboratory (s2(Laboratories)), between-day (s2(Days)) and between-replicate (s2(Replicates)). The variances of repeatability (s2r) and reproducibility (s2R) were then calculated. The estimated uncertainty, derived from the precision estimates, seems to be concentration-dependent above a given threshold. This example of R-timolol illustrates how a laboratory can evaluate uncertainty in general.
http://hdl.handle.net/2268/9012
10.1002/elps.200500832

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