Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations

摘要: Analytical results are widely used to assess batch-by-batch conformity, pharmaceutical equivalence, as well in the development of drug products. Despite this, few papers describing measurement uncertainty estimation associated with these were found literature. Here, we described a simple procedure for estimating dissolution test acetaminophen tablets. A fractionate factorial design was define mathematical model that explains amount dissolved (%) function time (from 20 40 minutes), volume media 800 1000 mL), pH 2.0 6.8), and rotation speed 60 rpm). Using Monte Carlo simulations, estimated tablets (95.2 ± 1.0%), 95% confidence level. Rotation most important source uncertainty, contributing about 96.2% overall uncertainty. Finally, it is note calculated this paper reflects expected test, does not consider variations content acetaminophen.