Interlaboratory study of a NACE method for the determination of R-timolol content in S-timolol maleate: assessment of uncertainty

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DOIResolve DOI: http://doi.org/10.1002/elps.200500832
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TypeArticle
Journal titleElectrophoresis
Volume27
Issue12
Pages23862399; # of pages: 14
Subjectenv; interlaboratory study; nonaqueous capillary electrophoresis; reproducibility; R-Timolol; uncertainty estimation
AbstractAnalyses 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.
Publication date
LanguageEnglish
AffiliationNational Research Council Canada; NRC Biotechnology Research Institute
Peer reviewedNo
NRC number47266
NPARC number3539328
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Record identifierdfce42d8-8213-457b-a516-eb500b106ebd
Record created2009-03-01
Record modified2016-05-09
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