@conference{
author = "Čarapić, Marija and Marković, Bojan and Nikolić, Katarina and Agbaba, Danica",
year = "2022",
abstract = "Ziprasidone, bensiothiasol piperazynylindolone derivative is second generation
antipsychotic drug used for the treatment of schizophrenia and in acute maniac/mixed
episodes associated with bipolar disorder. It has unique G-protein coupled receptor binding
profile with relatively low propensity for weight gain (1). Recently, it became an official
active pharmaceutical ingredient in European Pharmacopoeia, where there are three official
chromatographic systems, one for the assay and two other for early-eluiting and late-eluting
impurities. Therefore, the purpose of this investigation was to develop and validate a fast,
highly sensitive UHPLC-MS/MS method for the analysis of ziprasidone and its five impurities,
significantly differing in polarity and pKa. Separation was performed using Thermo ACCELA
UHPLC system (Thermo Scientific, Waltham, MA, USA) equipped with triple quad Mass
Spectrometer Thermo TSQ Quantum Access Max (Thermo Scientific, Waltham, MA, USA)
with a heated electro-spray ionization interface. Satisfactory chromatographic separation
was achieved using a gradient elution with mobile phase A (10mM ammonium formate
buffer, pH 4.7) and mobile phase B (acetonitrile) on a Acquity UPLC BEH C18 (50×2.1 mm,
1.7 μm) column with mobile phase flow rate of 300 μL/min. Sample injection volume was 10
μL. The analysis runtime was 7 minutes. The method was validated according to the
International Conference of Harmonization (ICH) guidelines and validation included
parameters such as specificity, linearity, accuracy, precision, limit of quantification and limit
of detection. The proposed rapid and sensitive method is convenient and reliable for the
assay and purity control in raw materials and in dosage forms (2)., Ziprasidon, derivat benzizotiazol piperazinilindolona, je antipsihotik druge generacije
koji se koristi za lečenje šizofrenije, kod akutnih maničnih ili mešovitih epizoda povezanih sa
bipolarnim poremećajem. Ima jedinstveni profil vezivanja za G protein-spregnute receptore
(GPCR) i relativno retko neželjeno dejstvo povećanja telesne težine (1). Nedavno je
monografija dve soli ziprasidona postala oficinalna u Evropskoj farmakopeji u kojoj se
ispitivanje vrši pomoću tri hromatografska sistema: ispitivanje sadržaja i dva odvojena
sistema za više i manje polarne nečistoće. Svrha ovog istraživanja bila da se razvije i validira
brza i visoko osetljiva UHPLC-MS/MS metoda za istovremeno ispitivanje ziprasidona i
njegovih pet nečistoća, koje se značajno razlikuju po polarnosti i pKa. Hromatografska
analiza je vršena na Thermo ACCELA UHPLC sistemu koji je spregnut sa tripl kvadrupolskim
masenim analizatorom Thermo TSQ Quantum Access Max (Thermo Scientific, Valtham, MA,
USA) sa elektrosprej jonizacijom na povišenoj temperaturi (HESI) kao jonskim izvorom.
Zadovoljavajuće razdvajanje dobijeno je korišć enjem gradijentog eluiranja sa mobilnom
fazom A (10 mM amonijum-formijat, pH 4,7) i mobilnom fazom B (acetonitril) na Acquity
UPLC BEH 50×2,1 mm, 1,7 μm (Waters) stacionarnoj fazi na temperaturi od 30ºC i pri
protoku mobilne faze od 300 μL/min. Zapremina injektovanja ispitivanih rastvora bila je
10 μL. Trajanje analize je 7 minuta (2). Metoda je validirana u skladu sa ICH (International
Council for Harmonisation) smernicom i pokazana je specifičnost metode, linearnost,
tačnost, preciznost, limit kvantifikacije i limit detekcije. Potvrđeno je da se brza i osetljiva
UHPLC-MS/MS metoda može primeniti za ispitivanje ziprasidona i njegovih nečistoća u
aktivnoj supstanci i doziranim oblicima.",
publisher = "Savez farmaceutskih udruženja Srbije (SFUS)",
journal = "Arhiv za farmaciju",
title = "Development and validation of UHPLC-MS/MS method for analysis of ziprasidone and its impurities, Razvoj i validacija UHPLC‐MS/MS metode za ispitivanje ziprasidona i njegovih nečistoća",
volume = "72",
number = "4 suplement",
pages = "S536-S537",
url = "https://hdl.handle.net/21.15107/rcub_farfar_4600"
}
