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

Authors

  • Daniel Cancelli Romero Univerity of São Paulo; Faculty of Pharmaceutical Sciences; Department of Pharmacy
  • Felipe Rebello Lourenço Univerity of São Paulo; Faculty of Pharmaceutical Sciences; Department of Pharmacy

DOI:

https://doi.org/10.1590/s2175-97902017000300163

Keywords:

Acetaminophen tablets/dissolution test/measurement uncertainty, Monte Carlo simulation

Abstract

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

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Published

2017-01-01

Issue

Section

Articles

How to Cite

Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations. (2017). Brazilian Journal of Pharmaceutical Sciences, 53(3), e00163-. https://doi.org/10.1590/s2175-97902017000300163