Optimizacija metode za određivanje rosuvastatina u gotovim farmaceutskim oblicima

master's thesis

• Title (english): Method optimization for determination of rosuvastatin in marketed formulations
• Author: Andrea Benković
• Mentor: Jasna Jablan (mentor)
• Committee member: Jasna Jablan (predsjednik povjerenstva)
• Committee member: Marijana Zovko Končić (član povjerenstva)
• Committee member: Maja Bival Štefan (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of analytical chemistry); Zagreb
• Defense date and country: 2021-04-12, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Inhibitori HMG-CoA reduktaze, odnosno statini, važna su skupina lijekova u primarnoj i sekundarnoj prevenciji kardiovaskularnih bolesti. Inhibicijom biosinteze kolesterola u jetri umanjuju njegove mnoge negativne učinke na organizam te se njihovom primjenom može smanjiti nastanak kardiovaskularnih incidenata. Rosuvastatin je najpotentniji lijek iz ove skupine dostupan na hrvatskom tržištu. Njegova kemijska svojstva i potentnost, u odnosu na prijašnje generacije statina, omogućuju primjenu u nižim dozama što posljedično dovodi do manje nuspojava od kojih neke, poput rabdomiolize, mogu ozbiljno ugroziti zdravlje i život pacijenta. Budući da se gotovo ne metabolizira CYP enzimima, pogodan je za kombiniranje s ostalim lijekovima koji su nužni u terapiji kardiovaskularnih bolesti, ali i drugih stanja.
Cilj ovog istraživanja bio je validirati UV-Vis metodu i primijeniti ju za točno i precizno određivanje koncentracije rosuvastatina u odabranim gotovim formulacijama. Usporedbom dobivenih rezultata i sadržaja deklariranog na ispitivanim uzorcima utvrđena je njihova podudarnost.
Analiza uzoraka provedena je na UV-Vis spektrofotometru. Prikupljena su tri uzorka filmom obloženih tableta rosuvastatin kalcija različitih proizvođača. Kvantitativnom ekstrakcijom rosuvastatina iz tableta dobivene su otopine koje su podvrgnute soniciranju i centrifugiranju, a zatim razrijeđene i analizirane. Nakon trodnevne analize dobiveni su podatci statistički obrađeni i izračunata je masa rosuvastatina u svakom uzorku. Dobiveni rezultati uspoređeni su s deklariranom masom rosuvastatina u tabletama. Odstupanja koja su uočena mogu biti posljedica sustavnih, grubih i slučajnih pogrešaka prilikom analize.

Abstract (english)

HMG-CoA inhibitors, also known as statins, are drugs with an important role in primary and secondary prevention of cardiovascular diseases. By inhibiting cholesterol biosynthesis in the liver, they reduce its negative effects on the body and lower the likelihood of cardiovascular adverse events. Rosuvastatin is the most effective statin on the Croatian market. Its chemical properties and potency allow us to use the drug in lower doses. Consequently, lower doses result in less side effects, some of which, such as rhabdomyolysis, pose a significant threat to patients’ life and health. In addition, because rosuvastatin is minimally metabolised by CYP enzymes, the probability of interactions with drugs that are used to treat cardiovascular or other diseases is reduced.
The aim of this study was to validate the UV-Vis method and investigate its application for a precise and accurate determination of rosuvastatin concentration in selected drug formulations. A comparison of the measured data with the data reported by the tablet manufacturers was performed to ensure consistency.
The measurements were carried out on a UV-Visible spectrophotometer. Three samples of film-coated tablets were purchased from different manufacturers. To quantitatively extract rosuvastatin from the formulations, the solutions were sonicated, centrifuged, and then diluted for the analysis. After a three-day measurement, the results were statistically analysed. The masses of rosuvastatin obtained were compared to those reported by the manufacturers. Some minor deviations that were found can be attributed to systematic and random errors.

• Keywords: rosuvastatin; UV-Vis spektrofotometrija; validacija analitičke metode
• Keywords (english): rosuvastatin; UV-Visible spectrophotometry; analytical method validation
• Language: croatian
• URN:NBN: urn:nbn:hr:163:572437
• 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: 2021-11-15 16:29:49