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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)
Metadata
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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
Funding / 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 ]
24
18
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/2379
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Vemić, Ana
AU  - Rakić, Tijana
AU  - Malenović, Anđelija
AU  - Medenica, Mirjana
PY  - 2015
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2379
AB  - 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 pramipexole and its five impurities is achieved fulfilling all the required criteria while the method validation proved its reliability.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles
VL  - 102
SP  - 314
EP  - 320
DO  - 10.1016/j.jpba.2014.09.031
ER  - 
@article{
author = "Vemić, Ana and Rakić, Tijana and Malenović, Anđelija and Medenica, Mirjana",
year = "2015",
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 pramipexole and its five impurities is achieved fulfilling all the required criteria while the method validation proved its reliability.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles",
volume = "102",
pages = "314-320",
doi = "10.1016/j.jpba.2014.09.031"
}
Vemić, A., Rakić, T., Malenović, A.,& Medenica, M.. (2015). Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles. in Journal of Pharmaceutical and Biomedical Analysis
Elsevier Science BV, Amsterdam., 102, 314-320.
https://doi.org/10.1016/j.jpba.2014.09.031
Vemić A, Rakić T, Malenović A, Medenica M. Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles. in Journal of Pharmaceutical and Biomedical Analysis. 2015;102:314-320.
doi:10.1016/j.jpba.2014.09.031 .
Vemić, Ana, Rakić, Tijana, Malenović, Anđelija, Medenica, Mirjana, "Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles" in Journal of Pharmaceutical and Biomedical Analysis, 102 (2015):314-320,
https://doi.org/10.1016/j.jpba.2014.09.031 . .

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