Ultra-performance liquid chromatography tandem mass spectrometry for the rapid, simultaneous analysis of ziprasidone and its impurities
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2019
Authors
Čarapić, MarijaNikolić, Katarina

Marković, Bojan

Petković, Miloš

Pavlović, Milena
Agbaba, Danica

Article (Published version)

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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 / ziprasidoneSource:
Biomedical Chromatography, 2019, 33, 2Publisher:
- Wiley, Hoboken
Funding / projects:
DOI: 10.1002/bmc.4384
ISSN: 0269-3879
PubMed: 30215855
WoS: 000456792500018
Scopus: 2-s2.0-85055113518
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PharmacyTY - JOUR AU - Čarapić, Marija AU - Nikolić, Katarina AU - Marković, Bojan AU - Petković, Miloš AU - Pavlović, Milena AU - Agbaba, Danica PY - 2019 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3329 AB - 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. PB - Wiley, Hoboken T2 - Biomedical Chromatography T1 - Ultra-performance liquid chromatography tandem mass spectrometry for the rapid, simultaneous analysis of ziprasidone and its impurities VL - 33 IS - 2 DO - 10.1002/bmc.4384 ER -
@article{ author = "Čarapić, Marija and Nikolić, Katarina and Marković, Bojan and Petković, Miloš and Pavlović, Milena and Agbaba, Danica", year = "2019", 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.", publisher = "Wiley, Hoboken", journal = "Biomedical Chromatography", title = "Ultra-performance liquid chromatography tandem mass spectrometry for the rapid, simultaneous analysis of ziprasidone and its impurities", volume = "33", number = "2", doi = "10.1002/bmc.4384" }
Čarapić, M., Nikolić, K., Marković, B., Petković, M., Pavlović, M.,& Agbaba, D.. (2019). Ultra-performance liquid chromatography tandem mass spectrometry for the rapid, simultaneous analysis of ziprasidone and its impurities. in Biomedical Chromatography Wiley, Hoboken., 33(2). https://doi.org/10.1002/bmc.4384
Čarapić M, Nikolić K, Marković B, Petković M, Pavlović M, Agbaba D. Ultra-performance liquid chromatography tandem mass spectrometry for the rapid, simultaneous analysis of ziprasidone and its impurities. in Biomedical Chromatography. 2019;33(2). doi:10.1002/bmc.4384 .
Čarapić, Marija, Nikolić, Katarina, Marković, Bojan, Petković, Miloš, Pavlović, Milena, Agbaba, Danica, "Ultra-performance liquid chromatography tandem mass spectrometry for the rapid, simultaneous analysis of ziprasidone and its impurities" in Biomedical Chromatography, 33, no. 2 (2019), https://doi.org/10.1002/bmc.4384 . .