Monte Carlo simulation for the evaluation of measurement uncertainty of pharmaceutical certified reference materials

摘要

The supplemental Guide to the Expression of Uncertainty Measurement (2008), which deals with the propagation of distributions, encourages the use of the Monte Carlo simulation (MCS) for estimating the uncertainty of measurands. This paper describes the application of this method to estimate the measurement uncertainty of active pharmaceutical ingredient (API) mass fractions of two certified reference materials (CRMs): metronidazole and captopril. The Monte Carlo results complied with the GUM results in terms of the critical value δ of 0.005 for metronidazole and 0.05 for captopril. Therefore, the Monte Carlo method validated the GUM through the expression of the API mass fraction with at least two decimal places.