Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles
Autor: | Ana Vemić, Mirjana Medenica, Anđelija Malenović, Tijana Rakić |
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Rok vydání: | 2015 |
Předmět: |
Clinical Biochemistry
Monte Carlo method Liquid chromatography Pharmaceutical Science 01 natural sciences Quality by Design Analytical Chemistry Chaotropic salts Pramipexole Quality-by-design Impurity Phase (matter) Drug Discovery Benzothiazoles Spectroscopy Reliability (statistics) Chromatography 010405 organic chemistry business.industry Chemistry 010401 analytical chemistry 0104 chemical sciences Chaotropic agent Design space Drug Contamination business Critical quality attributes Monte Carlo Method Quality assurance Chromatography Liquid |
Zdroj: | Journal of Pharmaceutical and Biomedical Analysis |
ISSN: | 0731-7085 |
DOI: | 10.1016/j.jpba.2014.09.031 |
Popis: | 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. |
Databáze: | OpenAIRE |
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