Validacija HPLC metode za određivanje onečišćenja u kalcij pantotenat aktivnoj supstanci

master's thesis

• Title (english): Validation of the HPLC method for the determination of impurities in the active substance calcium pantothenate
• Author: Anica Ćužić
• Mentor: Danijela Ašperger (mentor)
• Mentor: Domagoj Vukčević (komentor)
• Committee member: Danijela Ašperger (predsjednik povjerenstva)
• Committee member: Dragana Vuk (član povjerenstva)
• Committee member: Kristina Tolić Čop (član povjerenstva)
• Granter: University of Zagreb; Faculty of Chemical Engineering and Technology; Zagreb
• Defense date and country: 2024-09-27, Croatia
• Scientific / art field, discipline and subdiscipline: TECHNICAL SCIENCES; Chemical Engineering

Abstract

Svrha rada je detaljno opisati postupak validacije za određivanje onečišćenja u aktivnoj supstanci kalcijevog pantotenata. Kalcijev pantotenat je kalcijeva sol vitamina B5 koja posjeduje antioksidacijska svojstva zbog čega je neophodna za razne metaboličke funkcije, uključujući metabolizam ugljikohidrata, proteina i masnih kiselina. Sudjeluje i u sintezi hemoglobina, kolesterola, lipida. Validacijski postupak proveden je u laboratorijima Kontrole kvalitete, Pliva Hrvatska prema internim propisima i pod GMP uvjetima. Sva provedena ispitivanja u skladu su s važećim regulatornim smjernicama, uključujući ICH smjernice i Europsku farmakopeju (Ph. Eur.). Kroz eksperimentalni dio rada validirana je Ph. Eur. metoda za određivanje onečišćenja u kalcijevom pantotenatu da bi se osiguralo da će predloženi postupak biti uspješno implementiran u laboratorijima Kontrole kvalitete.
HPLC tehnikom s TUV detektorom ispitani su validacijski parametri selektivnost, osjetljivost, preciznost, točnost, linearnost, robusnost te stabilnost SST otopine i otopine standarda.

Abstract (english)

The aim of this paper is to describe the validation procedure for impurities determination in Calcium Pantothenate active substance. Calcium Pantothenate is the calcium salt of vitamin B5 with antioxidant properties which makes it essential for various metabolic functions, including the metabolism of carbohydrates, proteins, and fatty acids. This vitamin is also involved in the synthesis of hemoglobin, cholesterol, lipids. The validation procedure was performed in the Quality Control laboratories, Pliva Hrvatska according to internal regulations and under GMP conditions. All tests performed are in accordance with current regulatory guidelines, including ICH guidelines and the European Pharmacopoeia (Ph. Eur.). Through the experimental part of the thesis, the Ph. Eur. procedure for impurities determination of Calcium Pantothenate active substance was validated to ensure that the proposed analytical method will be successfully implemented in Quality Control laboratories. The following validation parameters were tested using the HPLC technique with Tunable UV Detector, TUV: selectivity, sensitivity, precision, accuracy, linearity, robustness and stability of standard and SST solution.

• Keywords: validacija; kromatografija; kalcijev pantotenat
• Keywords (english): validation; chromatography; calcium pantothenate
• Language: croatian
• URN:NBN: urn:nbn:hr:149:612515
• Study programme: Title: Materials Science and Engineering - Graduate study; Study programme type: university; Study level: graduate; Academic / professional title: sveučilišni/a magistar/magistra inženjer/inženjerka kemijskog inženjerstva (sveučilišni/a magistar/magistra inženjer/inženjerka kemijskog inženjerstva)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2024-11-07 10:52:42