Razvoj i validacija metode za određivanje paracetamola u tabletama primjenom Ramanove spektroskopije

master's thesis

• Title (english): Development and validation of a method for determining paracetamol in tablets using Raman spectroscopy
• Author: Petra Ivanjko
• Mentor: Jasna Jablan (mentor)
• Committee member: Jasna Jablan (predsjednik povjerenstva)
• Committee member: Maja Bival Štefan (član povjerenstva)
• Committee member: Marijana Zovko Končić (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of analytical chemistry); Zagreb
• Defense date and country: 2020-10-05, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Paracetamol (acetaminofen) je danas u svijetu jedan od najčešće korištenih OTC lijekova. Koristi se za liječenje blage do umjerene boli i povišene tjelesne temperature, a nalazi se i u kombiniranim pripravcima za liječenje simptoma prehlade i gripe. Iako poznat kao jako siguran lijek, zbog visoke dostupnosti i široke primjene, postao je jedan od vodećih uzroka smrti među lijekovima zbog slučajnog ili namjernog predoziranja. Paracetamol je radi svog hepatotoksičnog djelovanja vodeći uzrok akutnog zatajenja jetre u SAD-u. Cilj rada bio je razviti i validirati metodu za određivanje paracetamola u tabletama primjenom Ramanove spektroskopije te primjenom validirane metode odrediti udio paracetamola u uzorcima tableta. Prije validacije metode, bilo je potrebno provesti preliminarna ispitivanja, kojima se odabralo najbolje punilo te najbolji laser za ispitivanje validacijskih parametara. Preliminarnim ispitivanjima, kao najbolje punilo, odabrana je laktoza. Kod validacije analitičke metode ispitivani su parametri: linearnost, homogenost, preciznost (ponovljivost i intermedijarna preciznost) te granica određivanja i dokazivanja. Rezultati provedenih validacijskih mjerenja za sve parametre uglavnom su se nalazili unutar postavljenih granica. Određena odstupanja mogu se objasniti pogreškom analitičara prilikom priprave uzorka. Primjenom validirane metode na realne uzorke, dobivene su vrijednosti udjela paracetamola u uzorcima tableta i uspoređene s deklariranim. U daljnjim istraživanjima primijenit će se kemometrijski pristup analizi podataka radi bolje kvantifikacije paracetamola u uzorcima.

Abstract (english)

Paracetamol (acetaminophen) is one of the most widely used OTC drugs in the world today. It is used to treat mild to moderate pain and fever, and it is also found in combined preparations to treat cold and flu symptoms. Although known as a very safe drug, highly available and widely applicable, it has become one of the leading causes of death when drugs are concerned, due to accidental or intentional overdose. Paracetamol is the leading cause of acute liver failure in the United States because of its hepatotoxic effects. The aim of this study was to develop and validate a method for determination of paracetamol in tablets, using Raman spectroscopy and to use this validated method to determine the proportion of paracetamol in tablet samples. Prior to the validation of the method, it was necessary to conduct preliminary tests to select the best filler and the best laser for testing validation parameters. Preliminary test showed that lactose was the best filler. During the validation of the analytical method, following parameters were examined: linearity, homogeneity, precision (repeatability and intermediate precision) and the limit of determination and quantification. The results of the validation measurements, performed for all parameters, were generally within the set limits. Certain deviations can be explained by the analyst's error in preparing the sample. By applying the validated method to real samples, paracetamol content in tablet samples was obtained and compared to the theoretical ones. In further research, a chemometric approach to dana analysis will be applied in order to improve quantification of paracetamol in the samples.

• Keywords: Ramanova spektroskopija; paracetamol; validacija analitičke metode
• Keywords (english): Raman spectroscopy; paracetamol; validation
• Language: croatian
• URN:NBN: urn:nbn:hr:163:398952
• Study programme: Title: Pharmacy; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: magistar/magistra farmacije (magistar/magistra farmacije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Embargoed access; Embargo expiration date: 2024-10-05
• Created on: 2022-08-26 12:20:49