Development of an analytical method for the determination of pimavanserin and its impurities applying analytical quality by design principles as a risk-based strategy.

Journal of Pharmaceutical and Biomedical Analysis
Irena RadićSandra Babić

Abstract

Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. As it is a relatively new drug on the market, limited number of pharmacokinetic information and analytical methods are available. This paper presents an ultra-high performance chromatography for the simultaneous determination of pimavanserin and its four process impurities. The method was developed applying analytical quality by design (AQbD) principles as a risk-based approach. Critical method attributes (CMAs) were selected as a resolution between the worst separated compounds (impurity B and impurity C), a duration of analysis defined by the retention time of the last eluting peak (impurity D), a capacity factor of the first eluted impurity (impurity A), a tailing factor and a theoretical plate number. Risk assessment in the early stage of method development pointed out critical method parameters (CMPs): column temperature, gradient time and pH-value of the mobile phase (water phase, eluent A). Design of experiments (DoE), using DryLab®4 software, was applied to evaluate the influence of CMPs on CMAs and to determine method operable design region (MODR). Based on the risk assess...Continue Reading

References

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Sep 4, 2012·Analytical and Bioanalytical Chemistry·Serena OrlandiniSandra Furlanetto
Mar 27, 2013·Journal of Pharmaceutical and Biomedical Analysis·Róbert KormányHans-Jürgen Rieger
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May 28, 2019·Journal of Pharmaceutical and Biomedical Analysis·Irena Kasagić-Vujanović, Biljana Jančić-Stojanović

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