title: Uncertainty evaluation in the chloroquine phosphate potentiometric titration: application of three different approaches.
abstract: A measurement result cannot be properly interpreted if not accompanied by its uncertainty. Several methods to estimate uncertainty have been developed. From those methods three in particular were chosen in this work to estimate the uncertainty of the Eu. Ph. chloroquine phosphate assay, a potentiometric titration commonly used in medicinal control laboratories. The famous error-budget approach (also called bottom-up or step-by-step) described by the ISO Guide to the expression of Uncertainty in Measurement (GUM) was the first method chosen. It is based on the combination of uncertainty contributions that have to be directly derived from the measurement process. The second method employed was the Analytical Method Committee top-down which estimates uncertainty through reproducibility obtained during inter-laboratory studies. Data for its application were collected in a proficiency testing study carried out by over 50 laboratories throughout Europe. The last method chosen was the one proposed by Barwick and Ellison. It uses a combination of precision, trueness and ruggedness data to estimate uncertainty. These data were collected from a validation process specifically designed for uncertainty estimation. All the three approaches presented a distinctive set of advantages and drawbacks in their implementation. An expanded uncertainty of about 1% was assessed for the assay investigated.
authors.affiliation: Department of Drug Research and Evaluation, Istituto Superiore Di Sanità, Viale Regina Elena 299, 00161 Rome, Italy. andrea.rodomonte@iss.it
authors.forename: Andrea Luca
authors.initials: AL
authors.lastname: Rodomonte
authors.forename: Annalisa
authors.initials: A
authors.lastname: Montinaro
authors.forename: Monica
authors.initials: M
authors.lastname: Bartolomei
mesh_terms: D002738:Chloroquine / Q000031:analogs & derivatives* / Q000032:analysis; D011199:Potentiometry; D035501:Uncertainty
chemical_list: C023676:chloroquine diphosphate; D002738:Chloroquine