Određivanje potencijalno genotoksičnih onečišćenja u ceritinibu vezanim sustavom tekućinska kromatografija-tandemna spektrometrija masa

master's thesis

• Title (english): Determination of potentially genotoxic impurities in ceritinib by liquid chromatography- tandem mass spectrometry
• Author: Vedrana Jurković
• Mentor: Nives Galić (mentor)
• Committee member: Nives Galić (predsjednik povjerenstva)
• Committee member: Biserka Prugovečki (član povjerenstva)
• Committee member: Vesna Petrović Peroković (član povjerenstva)
• Committee member: Snežana Miljanić (član povjerenstva)
• Granter: University of Zagreb; Faculty of Science; (Department of Chemistry); Zagreb
• Defense date and country: 2018-02-28, Croatia
• Scientific / art field, discipline and subdiscipline: NATURAL SCIENCES; Chemistry

Abstract

Ceritinib je farmaceutik koji se koristi pri liječenju specifičnog oblika tumora pluća. Djeluje
kao inhibitor kinaze aplastičnog limfoma (ALK). Razna onečišćenja koja nastaju tijekom
proizvodnje ili razgradnjom djelatne tvari mogu utjecati na neka svojstva lijeka, stoga važeći
standardi i zakonske regulative zahtijevaju od farmaceutske industrije proizvodnju djelatne
tvari visoke čistoće, te detaljno poznavanje onečišćenja prisutnih u djelatnoj tvari i gotovom
lijeku. Ubrzani razvoj... More moderne analitičke instrumentacije rezultirao je razvojem izrazito
selektivnih i osjetljivih analitičkih metoda koje mogu odgovoriti na ove zahtjeve jer
omogućavaju određivanje ne samo djelatne tvari nego i onečišćenja prisutnih u lijeku. U
ovom radu validirana je metoda za kvantitativno određivanje genotoksičnih onečišćenja
ceritiniba primjenom vezanog sustava tekućinska kromatografija - tandemna spektrometrija
masa (LC-MS/MS). Less

Abstract (english)

Ceritinib is a pharmaceutical used to treat a specific type of lung cancer. This molecule acts as
an inhibitor of anaplastic lymphoma kinase (ALK). Various pollutants that are formed during
the production or degradation of active substances may affect some drug properties, so valid
standards and legislation require production of highly pure active substances and detailed
knowledge of the contaminants present in the active substance and in the final product. The
accelerated... More development of modern analytical instruments has resulted in the development of
highly selective and sensitive analytical methods that fulfil to these requirements because they
enable the determination of not only active substances but also contaminants present in the
drug. In this work, a quantitative method for the determination of genotoxic impurities in
ceritinib by hyphenated system high performance liquid chromatography-tandem mass
spectrometry (LC-MS/MS) was validated. Less

• Keywords: ceritinib; HPLC; MS/MS; onečišćenja; validacija
• Keywords (english): ceritinib; HPLC; MS/MS; impurities; validation
• Language: croatian
• URN:NBN: urn:nbn:hr:217:674676
• Study programme: Title: Graduate university studies in chemistry; specializations in: Research programme; Course: Research programme; Study programme type: university; Study level: graduate; Academic / professional title: magistar/magistra kemije (magistar/magistra kemije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access; Embargo expiration date: 2020-02-28
• Created on: 2018-02-28 14:27:08