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master's thesis
Validacija HPLC metode za određivanje onečišćenja u kalcij pantotenat aktivnoj supstanci
Zagreb: University of Zagreb, Faculty of Chemical Engineering and Technology, 2024. urn:nbn:hr:149:612515
Ćužić, Anica
University of Zagreb
Faculty of Chemical Engineering and Technology

Institutional repository: Repository of Faculty of Chemical Engineering and Technology University of Zagreb

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Ćužić, A. (2024). Validacija HPLC metode za određivanje onečišćenja u kalcij pantotenat aktivnoj supstanci (Master's thesis). Zagreb: University of Zagreb, Faculty of Chemical Engineering and Technology. Retrieved from https://urn.nsk.hr/urn:nbn:hr:149:612515

Ćužić, Anica. "Validacija HPLC metode za određivanje onečišćenja u kalcij pantotenat aktivnoj supstanci." Master's thesis, University of Zagreb, Faculty of Chemical Engineering and Technology, 2024. https://urn.nsk.hr/urn:nbn:hr:149:612515

Ćužić, Anica. "Validacija HPLC metode za određivanje onečišćenja u kalcij pantotenat aktivnoj supstanci." Master's thesis, University of Zagreb, Faculty of Chemical Engineering and Technology, 2024. https://urn.nsk.hr/urn:nbn:hr:149:612515

Ćužić, A. (2024). 'Validacija HPLC metode za određivanje onečišćenja u kalcij pantotenat aktivnoj supstanci', Master's thesis, University of Zagreb, Faculty of Chemical Engineering and Technology, accessed 20 December 2024, https://urn.nsk.hr/urn:nbn:hr:149:612515

Ćužić A. Validacija HPLC metode za određivanje onečišćenja u kalcij pantotenat aktivnoj supstanci [Master's thesis]. Zagreb: University of Zagreb, Faculty of Chemical Engineering and Technology; 2024 [cited 2024 December 20] Available at: https://urn.nsk.hr/urn:nbn:hr:149:612515

A. Ćužić, "Validacija HPLC metode za određivanje onečišćenja u kalcij pantotenat aktivnoj supstanci", Master's thesis, University of Zagreb, Faculty of Chemical Engineering and Technology, Zagreb, 2024. Available at: https://urn.nsk.hr/urn:nbn:hr:149:612515

Metadata
TitleValidacija HPLC metode za određivanje onečišćenja u kalcij pantotenat aktivnoj supstanci
Title (english)Validation of the HPLC method for the determination of impurities in the active substance calcium pantothenate
AuthorAnica Ćužić
MentorDanijela Ašperger (mentor)
MentorDomagoj Vukčević (komentor)
Committee memberDanijela Ašperger (predsjednik povjerenstva)
Committee memberDragana Vuk (član povjerenstva)
Committee memberKristina Tolić Čop (član povjerenstva)
GranterUniversity of Zagreb
Faculty of Chemical Engineering and Technology
Zagreb
Defense date and country2024-09-27, 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
Keywords (english)
Languagecroatian
URN:NBNurn:nbn:hr:149:612515
Study programmeTitle: 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 resourceText
File originBorn digital
Access conditionsOpen access
Terms of useLicence In copyright icon
Created on2024-11-07 10:52:42