Quality by design in pharmaceutical analysis using computer simulation with UHPLC

Imre Molnár, Robert Kormány, Jenõ Fekete

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Abstract

In this study, the quality-by-design principle is applied instead of trial-and-error in the development of a liquid chromatography method. With few measurements, the appropriate stationary phase and chromatographic conditions such as the composition of mobile phase, gradient time, temperature, and pH can be determined. A mixture of an active pharmaceutical ingredient and its 13 impurities was analyzed on a short narrow-bore column (50 mm × 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 design-of-experiment–based predictions.

Original languageEnglish
JournalLC-GC Europe
Volume27
Issue number5
Publication statusPublished - May 1 2014

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ASJC Scopus subject areas

  • Analytical Chemistry

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