LAUSR

The aim of this work was to establish a mathematical model to identify the main source of measurement uncertainty, quantify each uncertainty component, and calculate the combined and expanded uncertainties for determination of the fraction of sulpiride dissolved from tablets by UV spectrophotometry. The uncertainties on the absorbance (sample and standard), volumetric flasks and volumetric pipettes have important influence on the overall uncertainty. The average sulpiride fraction released from six tablets was 75.5 %, with an expanded uncertainty of 3.7 % (k = 2). Uncertainty is a relevant tool in assessment of compliance or non-compliance of in-process and final pharmaceutical products. Evaluation of the uncertainty of the dissolution measurement contributes to scientific explanation and interpretation of testing data, and ensures the results to be more accurate, impartial and convincing when testing a sample against specification or legislation.