Reliability of simulated robustness testing in fast liquid chromatography, using state-of-the-art column technology, instrumentation and modelling software

The goal of this study was to evaluate the accuracy of simulated robustness testing using commercial modelling software (DryLab) and state-of-the-art stationary phases. For this purpose, a mixture of amlodipine and its seven related impurities was analyzed on short narrow bore columns (50×2.1mm, pac...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2014-02, Vol.89, p.67-75
Main Authors: Kormány, Róbert, Fekete, Jenő, Guillarme, Davy, Fekete, Szabolcs
Format: Article
Language:English
Subjects:
Amlodipine - chemistry
Chromatography, Liquid - instrumentation
Chromatography, Liquid - methods
Models, Chemical
Reproducibility of Results
Software
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Summary:The goal of this study was to evaluate the accuracy of simulated robustness testing using commercial modelling software (DryLab) and state-of-the-art stationary phases. For this purpose, a mixture of amlodipine and its seven related impurities was analyzed on short narrow bore columns (50×2.1mm, packed with sub-2μm particles) providing short analysis times. The performance of commercial modelling software for robustness testing was systematically compared to experimental measurements and DoE based predictions. We have demonstrated that the reliability of predictions was good, since the predicted retention times and resolutions were in good agreement with the experimental ones at the edges of the design space. In average, the retention time relative errors were
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2013.10.029