prikaz prve stranice dokumenta Validacija MEKC-MS/MS metode za određivanje abemacikliba, palbocikliba i ribocikliba u krvnoj plazmi
Embargo period 2026-04-18
master's thesis
Validacija MEKC-MS/MS metode za određivanje abemacikliba, palbocikliba i ribocikliba u krvnoj plazmi
Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry, 2024. urn:nbn:hr:163:705669
Domijan, 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

Cite this document

Domijan, L. (2024). Validacija MEKC-MS/MS metode za određivanje abemacikliba, palbocikliba i ribocikliba u krvnoj plazmi (Master's thesis). Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry. Retrieved from https://urn.nsk.hr/urn:nbn:hr:163:705669

Domijan, Lorena. "Validacija MEKC-MS/MS metode za određivanje abemacikliba, palbocikliba i ribocikliba u krvnoj plazmi." Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, 2024. https://urn.nsk.hr/urn:nbn:hr:163:705669

Domijan, Lorena. "Validacija MEKC-MS/MS metode za određivanje abemacikliba, palbocikliba i ribocikliba u krvnoj plazmi." Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, 2024. https://urn.nsk.hr/urn:nbn:hr:163:705669

Domijan, L. (2024). 'Validacija MEKC-MS/MS metode za određivanje abemacikliba, palbocikliba i ribocikliba u krvnoj plazmi', Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, accessed 02 September 2024, https://urn.nsk.hr/urn:nbn:hr:163:705669

Domijan L. Validacija MEKC-MS/MS metode za određivanje abemacikliba, palbocikliba i ribocikliba u krvnoj plazmi [Master's thesis]. Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry; 2024 [cited 2024 September 02] Available at: https://urn.nsk.hr/urn:nbn:hr:163:705669

L. Domijan, "Validacija MEKC-MS/MS metode za određivanje abemacikliba, palbocikliba i ribocikliba u krvnoj plazmi", Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, 2024. Available at: https://urn.nsk.hr/urn:nbn:hr:163:705669

Metadata
TitleValidacija MEKC-MS/MS metode za određivanje abemacikliba, palbocikliba i ribocikliba u krvnoj plazmi
Title (english)Validation of MEKC-MS/MS method for determination of abemaciclib, palbociclib and ribociclib in blood plasma
AuthorLorena Domijan
MentorMiranda Sertić (mentor)
Committee memberMiranda Sertić (predsjednik povjerenstva)
Committee memberMaja Ortner Hadžiabdić (član povjerenstva)
Committee memberPetra Turčić (član povjerenstva)
GranterUniversity of Zagreb
Faculty of Pharmacy and Biochemistry
(Department of pharmaceutical analysis)
Zagreb
Defense date and country2024-04-18, Croatia
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Pharmacy
Pharmacy
Abstract
HR+/HER2- rak dojke jedan je od najčešćih tipova karcinoma u svijetu, za čije se liječenje koristi kombinacija inhibitora CDK4/6 s endokrinom terapijom. Abemaciklib, palbociklib i ribociklib, selektivni su i reverzibilni inhibitori o ciklinima ovisnih kinaza, CDK 4 i 6. S obzirom na potrebu za istovremenim određivanjem ovih lijekova iz krvne plazme pacijentica, razvijena je metoda micelarne elektrokinetičke kromatografije spregnute s tandemskom spektrometrijom masa (MEKC-MS/MS). Kako bi se navedena metoda mogla implementirati u rutinske analize biokemijskih laboratorija i sa sobom donijeti prednosti visoke efektivnosti, selektivnosti i manjeg utroška materijala te omogućiti terapijsko praćenje inhibitora CDK4/6 s ciljem poboljšanja ishoda liječenja, bilo ju je potrebno validirati sukladno ICH M10 smjernicama za validaciju bioanalitičkih metoda. Linearnost, točnost i preciznost metode su validirane za abemaciklib u kalibracijskom području 50-500 ng/mL, za palbociklib 30-300 ng/mL i za ribociklib 500-5000 ng/mL. Na visokoj i niskoj QC koncentraciji, validirani su parametri utjecaja matrice i stabilnost uzoraka u autosampleru za svaki od tri inhibitora CDK4/6. Zaključno s validacijom ovih parametara, pokazano je kako je metoda prikladna za svoju namjenu.
Abstract (english)
HR+/HER- breast cancer is one of the most common types of carcinomas across the world, for which the therapy includes combination of CDK4/6 inhibitors with endocrine therapy. Abemaciclib, palbociclib and ribociclib are selective and reversible inhibitors of cyclin-dependent kinases, CDK 4 and 6. Due to the need for simultaneous determination of these drugs from the blood plasma of patients, a method of micellar electrokinetic chromatography coupled with tandem mass spectrometry (MEKC-MS/MS) was developed. In order for the above method to be implemented in routine analyses in biochemical laboratories and to bring with it the advantages of higher effectiveness, selectivity and lower material consumption, while enabling therapeutic monitoring of CDK4/6 inhibitors with the aim of improving treatment outcomes, it was necessary to validate it in accordance with ICH M10 Guideline for the validation of bioanalytical methods. Linearity, accuracy, and precision of the method were validated in the calibration range of 50-500 ng/mL for abemaciclib, 30-300 ng/mL for palbociclib and 500-5000 ng/mL for ribociclib. Validation parameters matrix effect and stability in autosampler were validated for all of the three CDK4/6 inhibitors on the high and low QC (Quality control) concentrations, respectively to the ICH M10 Guideline. In conclusion, with validation of these parameters, it was shown that the method is suitable for its purpose.
Keywords
Keywords (english)
Languagecroatian
URN:NBNurn:nbn:hr:163:705669
Study programmeTitle: Pharmacy - integrated undergraduate and graduate - university study
Study programme type: university
Study level: integrated undergraduate and graduate
Academic / professional title: sveučilišni magistar farmacije (sveučilišni magistar farmacije)
Type of resourceText
File originBorn digital
Access conditionsEmbargoed access
Embargo expiration date: 2026-04-18
Terms of useLicence In copyright icon
Created on2024-06-14 12:10:28