Comparative study of performances of UHPLC-MS/MS and HPLC/UV methods for analysis of ziprasidone and its main impurities

• Autorzy: Čarapić Marija , Marković Bojan , Pavlovic Milena , Agbaba Danica , Nikolic Katarina

Identyfikatory

DOI

10.1556/1326.2022.01060

• Języki publikacji: EN

Abstrakty

EN

Ziprasidone is the second generation antipsychotic drug with unique multipotent G-protein-coupled (GPCR) receptor binding profile. Since ziprasidone is a highly lipophilic and unstable compound, development of efficient method for a concurrent assay of ziprasidone and its main impurities was a very challenging task. The UHPLC-MS/MS method that we developed for simultaneous determination of ziprasidone and its main impurities (BITP, Chloroethyl-chloroindolinone, Zip-oxide, Zip-dimer, and Zip-BIT) was compared with some other related HPLC-UV methods of our own and other authorship. An increase of the mobile phase pH value from 2.5 to 4.7 units in the examined analytical methods influenced elution order of the investigated compounds. It was found out that the UHPLC-MS/MS method is more selective and sensitive than the earlier developed HPLC-UV method. Similar to our earlier HPLC-UV method, the UHPLC-MS/MS method is linear with a correlation coefficient (r) above 0.99 for all the analysed compounds, but with a negligibly lower precision and accuracy. Finally, with shorter analysis time, smaller column size and reduction of solvent consumption, UHPLC-MS/MS is assumed as a greener method than HPLC-UV for the ziprasidone purity assay. After transfer of the UHPLC-MS/MS method to the UHPLC-DAD system, suitability of the UHPLC-DAD method for routine control of ziprasidone and its main impurities is examined and confirmed based on the retained good selectivity, resolution and short analysis time.

Słowa kluczowe

EN

ziprasidone; validation; ultra high performance liquid chromatography; tandem mass spectrometry; impurities

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2023
• Tom: Vol. 35, no. 3
• Strony: 260--271
• Opis fizyczny: Bibliogr. 47 poz., rys., tab., wykr.

Twórcy

autor

Čarapić Marija

• Medicines and Medical Devices Agency of Serbia, Vojvode Stepe 458, 11000, Belgrade, Serbia

autor

Marković Bojan

• Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, PO Box 146,11000 Belgrade, Serbia

autor

Pavlovic Milena

• Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, PO Box 146,11000 Belgrade, Serbia

autor

Agbaba Danica

• Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, PO Box 146,11000 Belgrade, Serbia

autor

Nikolic Katarina

• Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, PO Box 146,11000 Belgrade, Serbia

• https://orcid.org/0000-0002-3656-9245

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