Validacija metode HPLC za određivanje onečišćenja u aktivnoj supstanci verapamilu

master's thesis

• Title (english): Validation of HPLC method for determination impurites in the verapamil active
• Author: Mislav Kaličanec
• Mentor: Iva Juranović Cindrić (mentor)
• Committee member: Iva Juranović Cindrić (predsjednik povjerenstva)
• Committee member: Jana Pisk (član povjerenstva)
• Committee member: Đani Škalamera (član povjerenstva)
• Committee member: Adriana Kenđel (član povjerenstva)
• Granter: University of Zagreb; Faculty of Science; (Department of Chemistry); Zagreb
• Defense date and country: 2023-12-13, Croatia
• Scientific / art field, discipline and subdiscipline: NATURAL SCIENCES; Chemistry

Abstract

Verapamil hidroklorid, poznatiji pod nazivima verapamil i iproveratril, je lijek iz skupine
lijekova koji blokiraju odnosno inhibiraju kanale kalcija i na taj način uspješno smanjuju
prolazak kalcijevih iona u stanicu. Lijek verapamil se koristi za tretiranje raznih zdravstvenih
tegoba kao što su aritmija, atrijalna tahikardija i visoki krvni tlak.
Osnovna ideja ovog diplomskog rada je provesti postupak validacije analitičke metode za
određivanje onečišćenja u aktivnoj supstanci verapamila prema propisanim regulatornim
kriterijima Europske farmakopeje (Ph. Eur.) i Plivinim standardnim operativnim protokolima.
Eksperimentalni dio validacije metode Ph. Eur. za određivanje onečišćenja u aktivnoj supstanci
verapamilu proveden je u laboratoriju Kontrole kvalitete, Pliva Hrvatska pod uvjetima dobre
proizvođačke prakse, kako bi se osiguralo da je predložena metoda na pravilan način integrirana
u sustav Kontrole kvalitete Pliva Hrvatska. U svrhu validacije kromatografske metode visoke
djelotvornosti s detektorom niza dioda za određivanje onečišćenja određeni su validacijski
parametri: selektivnost, osjetljivost, preciznost i stabilnost standarda i uzoraka.

Abstract (english)

Verapamil hydrochloride, better known as verapamil and ipoveratril, is a member of calcium
channel blocking agents drug class that blocks calcium channels i.e. inhibits calcium channels
and succesfully reduces the entry of calicum ions in the cell. Verapamil is used to treat many
health problem such as: arrythmia, atrial tachycardia and high blood pressure.
The main idea of this thesis is to show how to validate method for determination of impurities
in the verapamil active supstance by prescribed regulatory criteria of the European
Pharmacopoeia (Ph. Eur.) and Pliva Croatia standard operating procedure. Experimental part
of this validation method for determination of impurities in verapamil active supstance is
performed in Quality Control laboratory, Pliva Croatia with good manufacture practice
conditions to insure that proposed analytical method is suitbly implemented in Pliva QC. In
order to inspect following parameters: selectivity, sensitivity, precision and stability of
standards and sample solutions, the HPLC technique with Diode Array Detector is used.
(65 pages, 21 figures, 11 tables, 30 references, original in croatian language)

• Keywords: verapamil; HPLC; validacija; onečišćenja
• Keywords (english): verapamil; HPLC; validation; impurities
• Language: croatian
• URN:NBN: urn:nbn:hr:217:627690
• Study programme: Title: Graduate university studies in chemistry; specializations in: Graduate university studies in chemistry; Course: Graduate university studies in chemistry; Study programme type: university; Study level: graduate; Academic / professional title: sveučilišni/a magistar/magistra kemije (sveučilišni/a magistar/magistra kemije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2023-12-18 11:06:56