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Ultra-performance liquid chromatography tandem mass spectrometry for the rapid, simultaneous analysis of ziprasidone and its impurities

Authorized Users Only
2019
Authors
Carapić, Marija
Nikolić, Katarina
Marković, Bojan
Petković, Miloš
Pavlović, Milena
Agbaba, Danica
Article (Published version)
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Abstract
The separation and characterization of the unknown degradation product of second-generation antipsychotic drug ziprasidone are essential for defining the genotoxic potential of the compound. The aim of this study was to develop a simple UHPLC method coupled with tandem mass spectrometry (MS/MS) for chemical characterization of an unknown degradant, and the separation and quantification of ziprasidone and its five main impurities (I-V) in the raw material and pharmaceuticals. Chromatographic conditions were optimized by experimental design. The MS/MS fragmentation conditions were optimized individually for each compound in order to obtain both specific fragments and high signal intensity. A rapid and sensitive UHPLC-MS/MS method was developed. All seven analytes were eluted within the 7 min run time. The best separation was obtained on the Acquity UPLC BEH C-18 (50 x 2.1 mm x 1.7 mu m) column in gradient mode with ammonium-formate buffer (10 mm; pH 4.7) and acetonitrile as mobile phase,... with the flow rate of 0.3 mL min(-1) and at the column temperature of 30 degrees C. The new UHPLC-MS/MS method was fully validated and all validation parameters were confirmed. The fragmentation pathways and chemical characterization of an unknown degradant were proposed and it was confirmed that there are no structural alerts concerning genotoxicity.

Keywords:
chromatographic functions / degradation products / experimental design / tandem mass spectrometry / ziprasidone
Source:
Biomedical Chromatography, 2019, 33, 2
Publisher:
  • Wiley, Hoboken
Projects:
  • Synthesis, Quantitative Structure and Activity Relationship, Physico-Chemical Characterisation and Analysis of Pharmacologically Active Substances (RS-172033)

DOI: 10.1002/bmc.4384

ISSN: 0269-3879

PubMed: 30215855

WoS: 000456792500018

Scopus: 2-s2.0-85055113518
[ Google Scholar ]
URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/3329
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  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy

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