Razvoj i validacija analitičke metode za određivanje onečišćenja u ceritinib aktivnoj farmaceutskoj tvari

undergraduate thesis

• Title (english): Development and validation of an analytical method for the determination of impurities in the ceritinib active pharmaceutical substance
• Author: Ivan Bilmez
• Mentor: Sandra Babić (mentor)
• Committee member: Sandra Babić (predsjednik povjerenstva)
• Committee member: Dragana Mutavdžić Pavlović (član povjerenstva)
• Committee member: Jelena Macan (član povjerenstva)
• Granter: University of Zagreb; Faculty of Chemical Engineering and Technology; Zagreb
• Defense date and country: 2022-09-23, Croatia
• Scientific / art field, discipline and subdiscipline: NATURAL SCIENCES; Chemistry

Abstract

Ceritinib je farmaceutska tvar koja se koristi za liječenje odraslih bolesnika s uznapredovalim rakom pluća nemalih stanica. Ovaj lijek se koristi samo u slučajevima kada stanice raka imaju mutaciju uzrokovanu genom zvanim kinaza anaplastičnog limfoma, i u tom slučaju su osobe pozitivne na taj gen. Kako bismo mogli odvojiti naš farmaceutik od potencijalnih onečišćenja koja se u njemu nalaze potrebno je imati dobru kromatografsku metodu koju je zatim potrebno validirati. Validacija kromatografske metode je nužan korak u osiguravanju kvalitete proizvoda. To je postupak kojim se definiraju potrebni zahtjevi, provodi eksperimentalno ispitivanje izvedbenih karakteristika metode te daje potvrda o zadovoljenosti postavljenih zahtjeva. Cilj ovog rada bio je razviti i validirati metodu za određivanje poznatih onečišćenja u ceritinib aktivnoj farmaceutskoj tvari. Tekućinska kromatografija visoke djelotvornosti (HPLC) je tehnika korištena u ovom radu. Tijekom validacije ispitane su sljedeće izvedbene karakteristike metode: specifičnost/selektivnost, linearnost, radno područje, preciznost (ponovljivost), granica kvantifikacije, granica detekcije, stabilnost otopine te robusnost. Granica detekcije iznosi 105 ppm, dok granica kvantifikacije iznosi 350 ppm.

Abstract (english)

Ceritinib is a pharmaceutical substance used to treat adult patients with advanced non-small cell lung cancer (NSCLC). This medicine is only used in cases where cancer cells have a mutation caused by gene called anaplastic lymphoma kinase (ALK), and in that case person is positive for that gene. In order to be able to separate our pharmaceutical from potential impurities found in it, it is necessary to have a good chromatographic method, which then needs to be validated. Validation of the chromatographic method is a necessary step in ensuring product quality. It is a procedure that defines the necessary requirements, conducts an experimental test of the performance characteristics of the method, and provides confirmation of the satisfaction of the set requirements. The aim of this study is to develop and validate a method for the determination of known impurities in the active pharmaceutical substance ceritinib. High performance liquid chromatography (HPLC) is the technique used in this work. During the validation, the following performance characteristics of the method were examined: specificity/selectivity, linearity, working range, precision (reproducibility), quantification limit, detection limit, solution stability and robustness.

• Keywords: ceritinib; onečišćenja; HPLC; validacija kromatografske metode.
• Keywords (english): ceritinib; impurities; HPLC; validation of chromatographic method
• Language: croatian
• URN:NBN: urn:nbn:hr:149:567855
• Study programme: Title: Chemical Engineering - Undergraduate study; Study programme type: university; Study level: undergraduate; Academic / professional title: sveučilišni/a prvostupnik/ prvostupnica (baccalaureus/baccalaurea) inženjer/inženjerka kemijskog inženjerstva (sveučilišni/a prvostupnik/ prvostupnica (baccalaureus/baccalaurea) inženjer/inženjerka kemijskog inženjerstva)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access; Embargo expiration date: 2023-10-01
• Created on: 2023-02-17 13:46:52