Razvoj UHPLC metode za određivanje elvitegravira prema načelima kvalitete ugrađene u dizajn primjenom računalnog programa Fusion QbD

master's thesis

• Title (english): Development of a UHPLC method for the determination of elvitegravir using quality by design principles and Fusion QbD software
• Author: Viktorija Gorički
• Mentor: Sandra Babić (mentor)
• Committee member: Sandra Babić (predsjednik povjerenstva)
• Committee member: Irena Škorić (član povjerenstva)
• Committee member: Martina Biošić (član povjerenstva)
• Granter: University of Zagreb; Faculty of Chemical Engineering and Technology; Zagreb
• Defense date and country: 2021-07-08, Croatia
• Scientific / art field, discipline and subdiscipline: NATURAL SCIENCES; Chemistry

Abstract

Cilj ovog rada bio je razviti i validirati analitičku metodu za određivanje aktivnog farmaceutskog sastojka, elvitegravira te njegovih poznatih onečišćenja prema načelima kvalitete ugrađene u dizajn. Razvoj analitičkih metoda svakako je važan korak u procesu razvoja i proizvodnji lijekova. On zauzima ključnu ulogu u daljnjim proizvodnim procesima kroz sve faze životnog ciklusa lijeka. Stoga je važno da razvijena analitička metoda bude pouzdana, precizna, robusna i selektivna. Princip kvalitete ugrađene u dizajn pruža nam brojne benefite nad tradicionalnim pristupom, a njegovim prihvaćanjem kontinuirano poboljšavamo robusnost proizvodnog procesa, kvalitetu proizvoda i produktivnost. U ovom radu, slijedeći principe kvalitete ugrađene u dizajn te korištenjem programa Fusion AETM uspješno je razvijena i optimirana kromatografska metoda. Razvijena metoda je validirana čime je dokazana njena prikladnost za određivanje elvitegravira.

Abstract (english)

The aim of this study was to develop and validate an analytical method for the determination of the active pharmaceutical ingredient, elvitegravir and its known impurities according to the principles of quality by design. The development of analytical methods is certainly an important step in the process of drug development and production. It plays a key role in further production processes through all stages of the drug life cycle. Therefore, the developed analytical method must be reliable, accurate, robust and selective. The principle of quality by design provides us with numerous benefits over the traditional approach and by accepting it, we continuously improve the robustness of the production process, product quality and productivity. In this paper, following the principles of quality by design and using the Fusion AETM software, the chromatographic method was successfully developed and optimized. The developed method was validated, which proved its applicability for the determination of elvitegravir.

• Keywords: elvitegravir; UHPLC; kvaliteta ugrađena u dizajn; Fusion AETM
• Keywords (english): elvitegravir; UHPLC; quality by design; Fusion AETM
• Language: croatian
• URN:NBN: urn:nbn:hr:149:932565
• Study programme: Title: Chemical Engineering - Graduate study; Study programme type: university; Study level: graduate; Academic / professional title: magistar/magistra inženjer/inženjerka kemijskog inženjerstva (magistar/magistra inženjer/inženjerka kemijskog inženjerstva)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access; Embargo expiration date: 2023-01-01
• Created on: 2023-04-06 13:24:33