Razvoj i validacija metode fluidne kromatografije pri superkritičnim uvjetima za određivanje onečišćenja u aktivnoj farmaceutskoj tvari Elvitegraviru

master's thesis

• Title (english): Development and validation of supercritical fluid chromatography method for Elvitegravir active pharmaceutical ingredient impurities detemination
• Author: Antonija Radić
• Mentor: Nives Galić (mentor)
• Committee member: Nives Galić (predsjednik povjerenstva)
• Committee member: Ines Primožič (član povjerenstva)
• Committee member: Biserka Prugovečki (član povjerenstva)
• Committee member: Snežana Miljanić (član povjerenstva)
• Granter: University of Zagreb; Faculty of Science; (Department of Chemistry); Zagreb
• Defense date and country: 2019-02-21, Croatia
• Scientific / art field, discipline and subdiscipline: NATURAL SCIENCES; Chemistry

Abstract

Elvitegravir je inhibitor enzima HIV-1 integraze koji se u kombinaciji s drugim lijekovima
koristi za lijeĉenje virusa humane imunodeficijencije (HIV). Tijekom procesa proizvodnje ili
razgradnje aktivne farmaceutske tvari mogu nastati razna oneĉišćenja koja utjeĉu na kvalitetu
i sigurnost lijeka. OdreĊivanje ĉistoće lijeka ukljuĉuje analitiĉke metode kojima je moguće
detektirati, identificirati, strukturno karakterizirati i kvantitativno odrediti oneĉišćenja u
aktivnoj farmaceutskoj tvari kao i u samom lijeku. U ovom radu razvijena je brza i uĉinkovita
metoda fluidne kromatografije pri superkritiĉnim uvjetima za analizu oneĉišćenja
Elvitegravira primjenom detektora s nizom dioda. Razvijena metoda takoĊer je i validirana
odreĊivanjem sljedećih parametara validacije: specifiĉnost, granica kvantifikacije, preciznost,
linearnost i toĉnost.

Abstract (english)

Elvitegravir is an HIV-1 integrase enzyme inhibitor which, in combination with other drugs is
used to treat human immunodeficiency virus (HIV). During the process of production or
degradation of the active pharmaceutical substance, various impurities are produced that
affect quality and safety of the drug. Determining the purity of the drug includes analytical
methods that can detect, identify, structure and quantitatively determine the impurities in the
active pharmaceutical substance as well as in the drug itself. In this paper, a fast and efficient
supercritical fluid chromatography (SFC) method for the analysis of impurities has been
developed by using a diode array detector. The developed method is also validated by
determining the following validation parameters: specificity, limit of quantification, precision,
linearity and accuracy.

• Keywords: Elvitegravir; oneĉišćenja; SFC; validacija
• Keywords (english): Elvitegravir; SFC; impurities; validation
• Language: croatian
• URN:NBN: urn:nbn:hr:217:699232
• 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: 2021-02-21
• Created on: 2019-03-14 09:43:05