Razvoj i validacija stabilitetno-indikativne metode za etrasimod primjenom tekućinske kromatografije visoke djelotvornosti

master's thesis

• Title (english): Development and validation of a stability-indicating method for etrasimod using high-perhormance liquid chromatography
• Author: Lara Crnac
• Mentor: Ana Mornar Turk (mentor)
• Committee member: Ana Mornar Turk (predsjednik povjerenstva)
• Committee member: Daniela Amidžić Klarić (član povjerenstva)
• Committee member: Goran Poje (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of pharmaceutical analysis); Zagreb
• Defense date and country: 2023-07-04, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Upalna bolest crijeva (eng. Inflammatory bowel disease, IBD) nepredvidiva je kronična bolest čija
je incidencija u stalnom porastu Prema lokali aciji patoloških promjena i ra ličitoj ahvaćenosti
stjenke probavnog sustava ra likujemo ulcero ni kolitis i Chronovu bolest Na tržištu se nala e se
brojni odobreni lijekovi a liječenje navedenih stanja, ali mnogi pacijenti ne reagiraju na dostupnu
terapiju, odgovor na terapiju tijekom liječenja smanjuje se ili terapija dovodi do o biljnih
nuspojava Upravo su i tog ra loga ra vijeni novi, sigurniji i učinkovitiji lijekovi – modulatori
S1P receptora. Etrasimod je novi lijek za pacijente s upalnom bolesti crijeva, a prvenstveno za one
oboljele od ulceroznog kolitisa. Selektivni je modulator S1PR1-a, S1PR4-a i S1PR5-a koji učinak
ostvaruje na način da inhibira promet limfocita i limfnih čvorova u krv Modulacija sfingo in-1-
fosfat receptora novi je put djelovanja lijekova koji se trenutačno ispituje ne samo a liječenje
upalnih bolesti crijeva, nego i za druge imunosne bolesti. U ovom je diplomskom radu razvijena
analitička metoda a odreĎivanje etrasimoda primjenom tekućinske kromatografije visoke
djelotvornosti Metoda je validirana sukladno meĎunarodno relevantnim smjernicama te je
utvrĎeno kako je metoda linearna, preci na i točna Predložena metoda može poslužiti kao temelj
za daljnje stabilitetno-indikativne studije.

Abstract (english)

Inflammatory bowel disease (IBD) is an unpredictable chronic condition whose incidence is
continuously increasing. Based on the localization of pathological changes and the various
involvement of the digestive tract wall, we can differentiate between ulcerative colitis and Crohn's
disease. There are numerous approved medications available on the market for treating these
conditions, but many patients do not respond to the available therapy, and the response to therapy
during treatment decreases over time or leads to serious side effects. It is precisely for this reason
that newer, safer, and more effective drugs have been developed – S1P receptor modulators.
Etrasimod is a novel drug for patients with inflammatory bowel disease, primarily those suffering
from ulcerative colitis. It is a selective modulator of S1PR1, S1PR4, and S1PR5 receptors, exerting
its effects by inhibiting the lymphocyte trafficking from lymph nodes to the bloodstream.
Modulation of sphingosine-1-phosphate receptors represents a new mechanism of action being
currently investigated not only for the treatment of inflammatory bowel diseases but also for other
immune disorders. In this thesis, an analytical method for the determination of etrasimod using
high-performance liquid chromatography has been developed. The method has been validated
according to internationally recognized guidelines, demonstrating linearity, precision, and
accuracy. The proposed method can serve as a basis for further stability-indicating studies.

• Keywords: upalna bolest crijeva; etrasimod; stabilitetno-indikativna metoda; validacija
• Keywords (english): inflammatory bowel disease; etrasimod; stability-indicating method; validation
• Language: croatian
• URN:NBN: urn:nbn:hr:163:933001
• 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: 2025-07-04
• Created on: 2023-11-17 14:55:12