Razvoj metode tekućinske kromatografije ultravisoke djelotvornosti za određivanje potencijalnih genotoksičnih onečišćenja u fosamprenaviru

master's thesis

• Title (english): Development of ultra-high performance liquid chromatographic method for determination of potentially genotoxic impurities in the fosamprenavir
• Author: Roberto Biškupić
• Mentor: Nives Galić (mentor)
• Committee member: Nives Galić (predsjednik povjerenstva)
• Committee member: Đani Škalamera (član povjerenstva)
• Committee member: Željka Soldin (član povjerenstva)
• Committee member: Sanda Rončević (član povjerenstva)
• Granter: University of Zagreb; Faculty of Science; (Department of Chemistry); Zagreb
• Defense date and country: 2022-12-15, Croatia
• Scientific / art field, discipline and subdiscipline: NATURAL SCIENCES; Chemistry

Abstract

Fosamprenavir je protuvirusni lijek koji se koristi za liječenje bolesnika zaraženih virusom
humane imunodeficijencije tipa 1. Prilikom proizvodnje lijekova mogu nastati nečistoće koje
je potrebno detaljno ispitati kako ne bi došlo do ugrožavanja zdravlja pacijenta.
U ovom diplomskom radu razvijena je metoda tekućinske kromatografije ultravisoke
djelotvornosti za analizu potencijalno genotoksičnih onečišćenja u lijeku Fosamprenavir,
prema načelima kvalitete ugrađene u dizajn, primjenom računalnog programa DryLab®.
Razvijena je metoda čiji eksperimentalni uvjeti iznose: pH-vrijednost mobilne faze 4,00;
temperatura kolone 60 °C i vrijeme gradijentnog eluiranja 3 minute. Pomoću razvijene
metode moguće je odrediti koncentraciju genotoksičnih onečišćenja u vrlo niskim
koncentracijama od 1 mg/L.

Abstract (english)

Fosamprenavir is an antiviral drug that is used to treat patients infected with the human
immunodeficiency virus type 1. During the production of drugs, impurities may arise that
must be examined in detail in order not to endanger the patient's health. In this thesis, an ultrahigh-performance liquid chromatography method was developed for the analysis of
potentially genotoxic contaminants in the drug Fosamprenavir, according to the principles of
quality by design, using the computer program DryLab®. A method was developed whose
experimental conditions were: pH-value of the mobile phase 4.00; column temperature 60 °C
and gradient elution time 3 minutes. Using the developed method, it is possible to determine
the concentration of genotoxic impurities in very low concentrations of 1 mg/L.

• Keywords: fosamprenavir; kvaliteta ugrađena u dizajn; genotoksična onečišćenja; UHPLC
• Keywords (english): fosamprenavir; quality by design; genotoxic impurities; UHPLC
• Language: croatian
• URN:NBN: urn:nbn:hr:217:293041
• 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: 2023-12-15
• Created on: 2022-12-23 10:15:50