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Optimizacija metode za ugotavljanje vsebnosti nečistote L v kalcijevem rosuvastatinatu = Optimization of a method for determination of the impurity L in rosuvastatin calcium : Master's Study Programme Laboratory BiomedicinePlanina Medin, LukaRosuvastatin spada v skupino statinov, zdravil za zdravljenje hiperlipidemije. Fiziološke ravni lipidov v krvi so pomemben dejavnik pri preprečevanju kardiovaskularnih bolezni. Statini so inhibitorji ... HMG-CoA reduktaze, encima v jetrih, ki sodeluje pri tvorbi holesterola. Rosuvastatin so patentirali v devetdesetih letih, odobrili za prodajo v ZDA leta 2003, od leta 2016 pa je na voljo tudi kot generično zdravilo. Veliko statinov, predvsem rosuvastatin, spada med najbolje prodajana zdravila na svetu. Strukturno je rosuvastatin zelo podoben ostalim sinteznim statinom, z izjemo sulfonamidne skupine, ki je prisotna le v rosuvastatinu. Cilj te magistrske naloge je bil optimizacija metode za ugotavljanje vsebnosti nečistote L v kalcijevem rosuvastatinatu. V začetnih fazah smo metodo skušali optimizirati z uporabo različnih kolon, nadaljevali smo s spremembo osnovnih kromatografskih pogojev (delež mobilnih faz, temperatura kolone, pretok). Ko tudi s spremembo kromatografskih pogojev nismo dobili želenih rezultatov, smo se lotili korenitejših sprememb: sprememba topila, sprememba sestave mobilne faze, zamenjava UPLC, ki ima binarno črpalko, za sistem UHPLC, ki ima kvartarno črpalko. Ko smo odkrili ustrezno metodo, ki je imela zadostno resolucijo in občutljivost, smo jo delno validirali. Preverili smo najpomembnejše validacijske parametre; mejo vrednotenja, linearnost, natančnost, točnost, faktor odzivnosti in stabilnost vzorcev. Z validacijo smo potrdili, da je nova metoda ustrezna za rutinsko uporabo.Type of material - master's thesis ; adult, seriousPublication and manufacture - Ljubljana : [L. Planina Medin], 2019Language - slovenianCOBISS.SI-ID - 4712049
Author
Planina Medin, Luka
Other authors
Pajk, Stane, 1983- |
Časar, Zdenko
Topics
Tekočinska kromatografija |
Statini |
rosuvastatin |
statini |
nečistota L |
optimizacija |
validacija
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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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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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Planina Medin, Luka | ![]() |
Pajk, Stane, 1983- | 28861 |
Časar, Zdenko | 19281 |
Source: Personal bibliographies
and: SICRIS
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