Validacija HPLC-DAD metode za analizu onečišćenja iz gumenih čepova u infuzijskim otopinama

master's thesis

• Title (english): Validation of HPLC-DAD method for analysis of leachables originating from rubber stoppers in infusion solutions
• Author: Lorena Dorić
• Mentor: Ana Mornar Turk (mentor)
• Committee member: Ana Mornar Turk (predsjednik povjerenstva)
• Committee member: Monika Barbarić (član povjerenstva)
• Committee member: Ana Karković Marković (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of pharmaceutical analysis); Zagreb
• Defense date and country: 2023-06-20, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Infuzijske otopine spadaju u jedne su od najprimjenjivanijih farmaceutskih oblika kod liječenja
akutno oboljelih pacijenata. Uzevši u obzir činjenice da se primjenjuju parenteralno te da spadaju u
farmaceutske oblike koji imaju visok rizik stupanja u interakcije s ambalažom, potencijalno prisutna
onečišćenja mogu predstavljati ugrozu za zdravlje krajnjih korisnika. Jedan od načina na koji
onečišćenja iz ambalaže mogu dospjeti u infuzijske otopine je prelaskom iz gumenih čepova u
formulaciju pri uvjetima skladištenja. Kako bi se mogla odrediti konačna sigurnost primjene
farmaceutskog pripravka, takva onečišćenja trebala bi se identificirati i kvantificirati. U svrhu ovog
rada validirana je i provedena HPLC-DAD metoda za kvantifikaciju jednog onečišćenja koje potječe
iz gumene ambalaže. Metoda je validirana sukladno sa smjernicama Međunarodnog vijeća za
harmonizaciju (ICH Q2(R2)) te je potom analizirano 37 uzoraka infuzijskih otopina. Od 37 uzoraka,
3 su sadržavala ispitivano onečišćenje u koncentraciji većoj od granice dokazivanja (LOD), a 1 je
uzorak sadržavao onečišćenje u koncentraciji većoj od granice određivanja (LOQ).

Abstract (english)

Infusion solutions are one of the most widely used pharmaceutical forms in the treatment of acutely
ill patients. Taking into consideration the fact that infusion solutions are administered parenterally
and that they belong to a group of pharmaceutical forms that pose a high risk of interacting with the
packaging, the potentially present impurities can pose a threat to the health of end users. One of the
ways in which impurities from packaging can get into infusion solutions is by leaching from rubber
stoppers to the formulation under storage conditions. In order to be able to determine the final safety
of use of the pharmaceutical, such impurities should be identified and quantified. For this thesis, a
HPLC-DAD method was validated and conducted for the quantification of one impurity that is
originating from rubber packaging. The method was validated in accordance with the guidelines
published by the International Council for Harmonization (ICH Q2(R2)) and then 37 samples of
infusion solutions were analyzed. Out of 37 samples, 3 contained the tested impurity in a
concentration higher than the limit of detection (LOD), and 1 sample contained the impurity in a
concentration higher than the limit of quantification (LOQ).

• Keywords: HPLC; infuzijske otopine; onečišćenje
• Keywords (english): HPLC; infusion solutions; impurity
• Language: croatian
• URN:NBN: urn:nbn:hr:163:792627
• 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: Open access
• Created on: 2023-11-17 15:10:58