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master's thesis
Validacija HPLC-DAD metode za analizu onečišćenja iz gumenih čepova u infuzijskim otopinama
Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry, 2023. urn:nbn:hr:163:792627
Dorić, Lorena
University of Zagreb
Faculty of Pharmacy and Biochemistry
Department of pharmaceutical analysis

Institutional repository: Repository of Faculty of Pharmacy and Biochemistry University of Zagreb

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Dorić, L. (2023). Validacija HPLC-DAD metode za analizu onečišćenja iz gumenih čepova u infuzijskim otopinama (Master's thesis). Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry. Retrieved from https://urn.nsk.hr/urn:nbn:hr:163:792627

Dorić, Lorena. "Validacija HPLC-DAD metode za analizu onečišćenja iz gumenih čepova u infuzijskim otopinama." Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, 2023. https://urn.nsk.hr/urn:nbn:hr:163:792627

Dorić, Lorena. "Validacija HPLC-DAD metode za analizu onečišćenja iz gumenih čepova u infuzijskim otopinama." Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, 2023. https://urn.nsk.hr/urn:nbn:hr:163:792627

Dorić, L. (2023). 'Validacija HPLC-DAD metode za analizu onečišćenja iz gumenih čepova u infuzijskim otopinama', Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, accessed 25 November 2024, https://urn.nsk.hr/urn:nbn:hr:163:792627

Dorić L. Validacija HPLC-DAD metode za analizu onečišćenja iz gumenih čepova u infuzijskim otopinama [Master's thesis]. Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry; 2023 [cited 2024 November 25] Available at: https://urn.nsk.hr/urn:nbn:hr:163:792627

L. Dorić, "Validacija HPLC-DAD metode za analizu onečišćenja iz gumenih čepova u infuzijskim otopinama", Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, 2023. Available at: https://urn.nsk.hr/urn:nbn:hr:163:792627

Metadata
TitleValidacija HPLC-DAD metode za analizu onečišćenja iz gumenih čepova u infuzijskim otopinama
Title (english)Validation of HPLC-DAD method for analysis of leachables originating from rubber stoppers in infusion solutions
AuthorLorena Dorić
MentorAna Mornar Turk (mentor)
Committee memberAna Mornar Turk (predsjednik povjerenstva)
Committee memberMonika Barbarić (član povjerenstva)
Committee memberAna Karković Marković (član povjerenstva)
GranterUniversity of Zagreb
Faculty of Pharmacy and Biochemistry
(Department of pharmaceutical analysis)
Zagreb
Defense date and country2023-06-20, 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
Keywords (english)
Languagecroatian
URN:NBNurn:nbn:hr:163:792627
Study programmeTitle: Pharmacy
Study programme type: university
Study level: integrated undergraduate and graduate
Academic / professional title: magistar/magistra farmacije (magistar/magistra farmacije)
Type of resourceText
File originBorn digital
Access conditionsOpen access
Terms of useLicence In copyright icon
Created on2023-11-17 15:10:58