prikaz prve stranice dokumenta Validacija HPLC metode za određivanje onečišćenja u raznim formulacijama Azitromicin praška za oralnu suspenziju
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master's thesis
Validacija HPLC metode za određivanje onečišćenja u raznim formulacijama Azitromicin praška za oralnu suspenziju
Zagreb: University of Zagreb, Faculty of Chemical Engineering and Technology, 2020. urn:nbn:hr:149:034469
Rimac, Marija
University of Zagreb
Faculty of Chemical Engineering and Technology

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

Cite this document

Rimac, M. (2020). Validacija HPLC metode za određivanje onečišćenja u raznim formulacijama Azitromicin praška za oralnu suspenziju (Master's thesis). Zagreb: University of Zagreb, Faculty of Chemical Engineering and Technology. Retrieved from https://urn.nsk.hr/urn:nbn:hr:149:034469

Rimac, Marija. "Validacija HPLC metode za određivanje onečišćenja u raznim formulacijama Azitromicin praška za oralnu suspenziju." Master's thesis, University of Zagreb, Faculty of Chemical Engineering and Technology, 2020. https://urn.nsk.hr/urn:nbn:hr:149:034469

Rimac, Marija. "Validacija HPLC metode za određivanje onečišćenja u raznim formulacijama Azitromicin praška za oralnu suspenziju." Master's thesis, University of Zagreb, Faculty of Chemical Engineering and Technology, 2020. https://urn.nsk.hr/urn:nbn:hr:149:034469

Rimac, M. (2020). 'Validacija HPLC metode za određivanje onečišćenja u raznim formulacijama Azitromicin praška za oralnu suspenziju', Master's thesis, University of Zagreb, Faculty of Chemical Engineering and Technology, accessed 26 November 2024, https://urn.nsk.hr/urn:nbn:hr:149:034469

Rimac M. Validacija HPLC metode za određivanje onečišćenja u raznim formulacijama Azitromicin praška za oralnu suspenziju [Master's thesis]. Zagreb: University of Zagreb, Faculty of Chemical Engineering and Technology; 2020 [cited 2024 November 26] Available at: https://urn.nsk.hr/urn:nbn:hr:149:034469

M. Rimac, "Validacija HPLC metode za određivanje onečišćenja u raznim formulacijama Azitromicin praška za oralnu suspenziju", Master's thesis, University of Zagreb, Faculty of Chemical Engineering and Technology, Zagreb, 2020. Available at: https://urn.nsk.hr/urn:nbn:hr:149:034469

Metadata
TitleValidacija HPLC metode za određivanje onečišćenja u raznim formulacijama Azitromicin praška za oralnu suspenziju
Title (english)Validation of HPLC method for determination of impurities in different formulations of Azithromycin powder for oral suspension
AuthorMarija Rimac
MentorDanijela Ašperger (mentor)
Committee memberDanijela Ašperger (predsjednik povjerenstva)
Committee memberSandra Babić (član povjerenstva)
Committee memberSvjetlana Krištafor (član povjerenstva)
GranterUniversity of Zagreb
Faculty of Chemical Engineering and Technology
Zagreb
Defense date and country2020-10-30, Croatia
Scientific / art field,
discipline and subdiscipline		NATURAL SCIENCES
Chemistry
Abstract
Azitromicin, koji pripada skupini makrolidnih antibiotika, koristi se za liječenje bakterijskih infekcija. Za njegovo otkriće 1981. godine, i proizvodnju vlastitim tehnološkim postupkom, zaslužan je PLIVIN istraživački tim. On je ujedno i velik doprinos znanosti, medicini i poboljšanju kvalitete života na globalnoj razini (Banić Tomišić, 2011). Na tržištu se nalazi u raznim oblicima i dozama. Cilj ovog rada je opisati postupak validacije za određivanje onečišćenja u proizvodu u obliku praška za oralnu suspenziju, u dozama od 100 mg/5 mL i 200 mg/5 mL. Sva ispitivanja su provedena prema ICH smjernicama i farmakopejama (USP i Ph. Eur.). Cijeli postupak validacije je proveden u laboratorijima tvrtke Pliva Hrvatska d.o.o., i to na dva načina: opcijom 1 (HPLC) i opcijom 2 (UPLC). Obje opcije su potpuno validirane te je dokazana njihova ekvivalencija, a u ovom radu je prikazana opcija 1.
Abstract (english)
Azithromycin, which belongs to the group of macrolide antibiotics, is used to treat bacterial infections. PLIVA's research team is responsible for its discovery in 1981, and also for its own technological production. It is also a great contribution to science, medicine and improving the quality of life at the global level (Banić Tomišić, 2011). It's available on the market in various forms and doses. The aim of this thesis is to describe a validation procedure for the determination of impurities in a product in the form of a powder for oral suspension, in doses of 100 mg/5 mL and 200 mg/5 mL. All studies were performed according to ICH guidelines and pharmacopoeias (USP and Ph. Eur.). The entire validation procedure was proved in the laboratories of Pliva Hrvatska d.o.o., in two options: option 1 (HPLC) and option 2 (UPLC). Both of the options are completely validated and their equivalence is proved, but this thesis presents option 1.
Keywords
Keywords (english)
Languagecroatian
URN:NBNurn:nbn:hr:149:034469
Study programmeTitle: Environmental Engineering - Graduate study
Study programme type: university
Study level: graduate
Academic / professional title: magistar/magistra inženjer/inženjerka ekoinženjerstva (magistar/magistra inženjer/inženjerka ekoinženjerstva)
Type of resourceText
File originBorn digital
Access conditionsClosed access
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Created on2022-07-19 11:44:38