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Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles

Authorized Users Only
2015
Authors
Vemić, Ana
Rakić, Tijana
Malenović, Anđelija
Medenica, Mirjana
Article (Published version)
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Abstract
The aim of this paper is to present a development of liquid chromatographic method when chaotropic salts are used as mobile phase additives following the QbD principles. The effect of critical process parameters (column chemistry, salt nature and concentration, acetonitrile content and column temperature) on the critical quality attributes (retention of the first and last eluting peak and separation of the critical peak pairs) was studied applying the design of experiments-design space methodology (DoE-DS). D-optimal design is chosen in order to simultaneously examine both categorical and numerical factors in minimal number of experiments. Two ways for the achievement of quality assurance were performed and compared. Namely, the uncertainty originating from the models was assessed by Monte Carlo simulations propagating the error equal to the variance of the model residuals and propagating the error originating from the model coefficients' calculation. The baseline separation of pramipe...xole and its five impurities is achieved fulfilling all the required criteria while the method validation proved its reliability.

Keywords:
Chaotropic salts / Quality-by-design / Design space / Liquid chromatography / Pramipexole
Source:
Journal of Pharmaceutical and Biomedical Analysis, 2015, 102, 314-320
Publisher:
  • Elsevier Science BV, Amsterdam
Projects:
  • Modelling of different chromatographic systems with chemometrical approach in pharmaceutical analysis (RS-172052)

DOI: 10.1016/j.jpba.2014.09.031

ISSN: 0731-7085

PubMed: 25459929

WoS: 000347277500039

Scopus: 2-s2.0-84908428492
[ Google Scholar ]
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URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/2379
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  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy

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