Robust UHPLC separation method development for multi-API product containing amlodipine and bisoprolol: The impact of column selection

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

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

This paper describes a new and fast ultra-high pressure liquid chromatographic separation of amlodipine and bisoprolol and all their closely related compounds, for impurity profiling purposes. Computer-assisted method development was applied and the impact of several state-of-the-art stationary phase column chemistries (50 x 2.1 mm, sub-2 μm, and core-shell type materials) on the achievable selectivity and resolution was investigated. The work was performed according to quality by design principles using design of experiment with three experimental factors; namely the gradient time (t G), temperature (T), and mobile phase pH. Thanks to modeling software, it was proved that the separation of all compounds was feasible on numerous column chemistries within

Original languageEnglish
Pages (from-to)1119-1127
Number of pages9
JournalChromatographia
Volume77
Issue number17-18
DOIs
Publication statusPublished - 2014

Fingerprint

Bisoprolol
Amlodipine
Application programming interfaces (API)
Design of experiments
Software
Impurities
Pressure
Temperature
Liquids

Keywords

  • Amlodipine
  • Bisoprolol
  • DryLab
  • Method development
  • Quality by design (QbD)
  • UHPLC

ASJC Scopus subject areas

  • Analytical Chemistry
  • Biochemistry
  • Clinical Biochemistry
  • Organic Chemistry

Cite this

Robust UHPLC separation method development for multi-API product containing amlodipine and bisoprolol : The impact of column selection. / Kormány, Róbert; Molnár, Imre; Fekete, J.; Guillarme, Davy; Fekete, Szabolcs.

In: Chromatographia, Vol. 77, No. 17-18, 2014, p. 1119-1127.

Research output: Contribution to journalArticle

Kormány, Róbert ; Molnár, Imre ; Fekete, J. ; Guillarme, Davy ; Fekete, Szabolcs. / Robust UHPLC separation method development for multi-API product containing amlodipine and bisoprolol : The impact of column selection. In: Chromatographia. 2014 ; Vol. 77, No. 17-18. pp. 1119-1127.
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