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Ocena ustreznosti analiznih postopkov za vrednotenje stabilnosti natrijevega pantoprazolata = Evaluation of analytical procedures for stability testing of pantoprazole sodium : magistrski študij industrijske farmacijeDurić, InesAnalizni postopki so kljucni za kontrolo kakovosti zdravilnih ucinkovin in zdravil. Z njimi tocno dolocamo identifikacijo, fizikalne lastnosti, vsebnost, necistote ter ucinkovitost zdravil od zacetka ... do konca roka uporabnosti. V sklopu magistrske naloge smo ocenjevali ustreznost novega analiznega postopka za testiranje stabilnosti pantoprazola v obliki natrijevega pantoprazolata. Eden od nacinov preverjanja primernosti analiznih postopkov za testiranje stabilnosti je, da zdravilo izpostavimo zelo stresnim pogojem, ki so ostrejši glede na obicajne okolijske (npr. zelo povišana temperatura). Tako preverimo sposobnost analiznega postopka ali nam res omogoca zaznavanje spremembe v kakovosti izdelka, npr. porast necistot. Eksperimentalno delo smo izvajali na zdravilnih ucinkovinah in tabletah pantoprazol dveh razlicnih proizvajalcev. Najprej smo morali izbrati ustrezne stresne pogoje, s katerimi smo želeli doseci le nastanek primarnih razkrojnih produktov. Glede na Ameriško in Evropsko farmakopejo znane necistote pantoprazola nam je uspelo identificirati, spremljali pa smo padec vsebnosti pantoprazola glede na porast necistot pri vseh izbranih stresnih pogojih. Ciljni delež necistot je bil med 5 in 20 %, kar je pri zelo stabilnih zdravilnih ucinkovinah težko doseci. To smo potrdili tudi v našem primeru. Ocenjujemo, da so bili nekateri pogoji za vzorce zdravilnih ucinkovin (npr. 0,1 M HCl in 0,3 % vodikov peroksid) preostri, kar je privedlo do nastanka sekundarnih in terciarnih razkrojnih produktov. Ciljni delež razkrojev smo bolj uspešno dosegli pri vzorcih tablet, kar najverjetneje pomeni, da je gastrorezistentna obloga uspešno zašcitila pantoprazol v vzorcih tablet. Ugotovili smo, da je pantoprazol nestabilen v kislem, pri višjih temperaturah in vlagi ter da je dovzeten za oksidacijo. Med drugim smo potrdili, da so kromatografski vrhovi pantoprazola in necistot v kromatogramih dobro loceni in spektralno homogeni. Z vsemi opažanji smo doprinesli k dejstvu, da predmetni postopki za testiranje stabilnosti pantoprazola ustrezajo svojemu namenu ter navsezadnje udejanjili naš glavni cilj.Type of material - master's thesis ; adult, seriousPublication and manufacture - Ljubljana : [I. Durić], 2023Language - slovenianCOBISS.SI-ID - 162830595
Author
Durić, Ines
Other authors
Pajk, Stane, 1983- |
Gams Petrišič, Marinka
Topics
Analizna kemija |
Zdravila |
stabilnost učinkovin |
stresne stabilnostne študije |
pantoprazol |
nečistote |
analizni postopki |
priprava vzorcev
Library/institution |
City | Acronym | For loan | Other holdings |
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Faculty of Pharmacy, Ljubljana | Ljubljana | FFALJ |
reading room 1 cop.
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DRS, in which the journal is indexed
Database name | Field | Year |
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Links to authors' personal bibliographies | Links to information on researchers in the SICRIS system |
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Durić, Ines | |
Pajk, Stane, 1983- | 28861 |
Gams Petrišič, Marinka | 28478 |
Source: Personal bibliographies
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