Establishing column batch repeatability according to Quality by Design (QbD) principles using modeling software

Norbert Rácz, Róbert Kormány, J. Fekete, Imre Molnár

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Column technology needs further improvement even today. To get information of batch-to-batch repeatability, intelligent modeling software was applied. Twelve columns from the same production process, but from different batches were compared in this work. In this paper, the retention parameters of these columns with real life sample solutes were studied. The following parameters were selected for measurements: gradient time, temperature and pH. Based on calculated results, batch-to-batch repeatability of BEH columns was evaluated. Two parallel measurements on two columns from the same batch were performed to obtain information about the quality of packing. Calculating the average of individual working points at the highest critical resolution (Rs,crit) it was found that the robustness, calculated with a newly released robustness module, had a success rate >98% among the predicted 36=729 experiments for all 12 columns. With the help of retention modeling all substances could be separated independently from the batch and/or packing, using the same conditions, having high robustness of the experiments.

Original languageEnglish
Pages (from-to)1-10
Number of pages10
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume108
DOIs
Publication statusPublished - Apr 1 2015

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Software
Technology
Temperature
Experiments

Keywords

  • DOE
  • DryLab
  • QbD
  • Robustness
  • UPLC-column comparison

ASJC Scopus subject areas

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

Cite this

Establishing column batch repeatability according to Quality by Design (QbD) principles using modeling software. / Rácz, Norbert; Kormány, Róbert; Fekete, J.; Molnár, Imre.

In: Journal of Pharmaceutical and Biomedical Analysis, Vol. 108, 01.04.2015, p. 1-10.

Research output: Contribution to journalArticle

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