Razvoj i validacija metode za određivanje loratadina u prisutnosti njegovih razgradnih produkata

master's thesis

• Title (english): Development and validation of method for determination of loratadine in the presence of its degradation products
• Author: Matea Rukavina
• Mentor: Nives Galić (mentor)
• Committee member: Nives Galić (predsjednik povjerenstva)
• Committee member: Davor Kovačević (član povjerenstva)
• Committee member: Đani Škalamera (član povjerenstva)
• Committee member: Sanda Rončević (član povjerenstva)
• Granter: University of Zagreb; Faculty of Science; (Department of Chemistry); Zagreb
• Defense date and country: 2023-10-18, Croatia
• Scientific / art field, discipline and subdiscipline: NATURAL SCIENCES; Chemistry

Abstract

Stabilnost farmakološki aktivnih spojeva utječe na kvalitetu, djelotvornost i sigurnost lijeka.
Izlaganje djelatne tvari različitim uvjetima razgradnje pruža direktan uvid u njezinu intrizičnu
stabilnost. Razvojem stabilitetno-indikativne metode, odnoso validiranog analitičkog postupka
moguće je kvantificirati smanjenje količine aktivnog farmaceutskog sastojka uslijed prisilne
razgradnje. Validacijom metode se dokazuje prikladnost mjernog postupka za prethodno
određenu svrhu, odnosno da metoda udovoljava zahtjevima uporabe. U sklopu ovog
diplomskog rada razvijena je i validirana metoda određivanja loratadina u prisutnosti njegovih
razgradnih produkata pomoću spregnutog sustava tekućinske kromatografije ultravisoke
djelotvornosti i spektrometrije masa visokog razlučivanja. Uz selektivnost, određene su i ostale
značajke metode poput linearnosti, preciznosti, granice detekcije i kvantifikacije analita te
robusnosti. Validacija je provedena u skladu s ICH smjernicama.

Abstract (english)

Stability of active pharmaceutical ingredient affects quality, efficacy, and safety of a drug.
Exposure of an active substance to various stress conditions provides direct insight in its
intrinsic stability. A stability-indicating method is a validated analytical procedure used to
quantitate the decrease in the amount of active pharmaceutical ingredient due to forced
degradation. Validation of the method provides the suitability of the measurement procedure
for a previously determined purpose, in other words, that the method meets the requirements of
use.The aim of this thesis is to develop and validate a new method for determination of
loratadine in the presence of its degradation products using ultrahigh performance liquid
chromatography coupled with high resolution mass spectrometry. Besides selectivity, other
validation parameters such as selectivity, precision, linearity, limits of detection and
quantification of the analyte and robustness are determined.

• Keywords: oratadin; spektrometrija masa; stabilitetno-indikativna metoda; validacija
• Keywords (english): oratadine; mass spectrometry; stability-indicating method; validation
• Language: croatian
• URN:NBN: urn:nbn:hr:217:358324
• 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: Embargoed access; Embargo expiration date: 2025-10-18
• Created on: 2023-10-20 10:25:26