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Lajin, B; Steiner, O; Fasshold, L; Zangger, K; Goessler, W.
The identification and chromatographic separation of a new highly analogous impurity of the active pharmaceutical ingredient icatibant.
Eur J Pharm Sci. 2019; 132(13):121-124 Doi: 10.1016/j.ejps.2019.03.003
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Leading authors Med Uni Graz: Lajin Bassam
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Abstract:: Icatibant is a peptidomimetic drug serving as a bradykinin-receptor antagonist and is approved in Europe and the United States for the treatment of hereditary angioedema attacks. We have detected an impurity with a high structural similarity to icatibant in pharmaceutical dosage forms using an optimized chromatographic method based on reversed phase high performance liquid chromatography with UV detection. The abundance of the impurity was around 1% relative to the icatibant peak following storage at room temperature for 1 month, and raised up to ~16% upon temperature stressing at 100 °C. The impurity was isolated by fraction collection and further purified by solid phase extraction for structural identification. NMR and high resolution mass spectrometric analyses revealed that this impurity results from isomerization in the N-terminal single amino acid residue. The new impurity may warrant particular attention due to its exceptional similarity to the active ingredient icatibant. Copyright © 2019 Elsevier B.V. All rights reserved.
Find related publications in this database (using NLM MeSH Indexing): Bradykinin - analogs & derivatives; Bradykinin - chemistry; Bradykinin - standards; Bradykinin B2 Receptor Antagonists - chemistry; Bradykinin B2 Receptor Antagonists - standards; Chromatography, High Pressure Liquid -; Drug Contamination -; Mass Spectrometry -; Molecular Structure -; Stereoisomerism -
Find related publications in this database (Keywords): Peptidomimetic drugs; HOE 140; Isomerization; Chromatography; Forced degradation; Icatibant; Firazyr (R)