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

Róbert Kormány, J. Fekete, Davy Guillarme, Szabolcs Fekete

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

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. ×. 2.1. mm, packed with sub-2. μm 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

Original languageEnglish
Pages (from-to)67-75
Number of pages9
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume89
DOIs
Publication statusPublished - Feb 15 2014

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Liquid chromatography
Liquid Chromatography
Software
Technology
Amlodipine
Testing
Impurities

Keywords

  • Column interchangeability
  • DryLab
  • Method development
  • Modelling software
  • Robustness
  • UHPLC

ASJC Scopus subject areas

  • Analytical Chemistry
  • Drug Discovery
  • Pharmaceutical Science
  • Spectroscopy
  • Clinical Biochemistry

Cite this

Reliability of simulated robustness testing in fast liquid chromatography, using state-of-the-art column technology, instrumentation and modelling software. / Kormány, Róbert; Fekete, J.; Guillarme, Davy; Fekete, Szabolcs.

In: Journal of Pharmaceutical and Biomedical Analysis, Vol. 89, 15.02.2014, p. 67-75.

Research output: Contribution to journalArticle

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