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Metilprednizolon i njegove srodne supstance u liofilizatu za rastvor za injekcije

dc.creatorSolomun, Ljiljana
dc.creatorIbrić, Svetlana
dc.creatorVajs, Vlatka
dc.creatorVucković, Ivan M.
dc.creatorVujić, Zorica
dc.date.accessioned2019-09-02T11:22:21Z
dc.date.available2019-09-02T11:22:21Z
dc.date.issued2010
dc.identifier.issn0352-5139
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/1426
dc.description.abstractIn this work, the behavior of the active pharmaceutical substances methylprednisolone (in a form of methylprednisolone sodium succinate) in finished pharmaceutical dosage form, i.e., freeze-dried powder for injections, was examined. The goal was to evaluate the chemical stabilities of methylprednisolone sodium succinate packaged in a dual chamber vial, as a specific container closure system. The effect of different parameters: temperature, moisture and light were monitored. The method proposed by United States Pharmacopeia was used to determine concentrations of methylprednisolone, as the sum of the concentration of methylprednisolone esters (17-hydrogen succinate and 21-hydrogen succinate) and free methylprednisolone. The HPLC method was used for stability evaluation of the active substance and determination of related substances. Four main degradation products were registered. Temperature has a major impact on the degradation process with the appearance of 3 degradation products (impurities B, C and D), while the presence of light caused an increasing content of impurity A. Identification of impurity B, C and D has been realized using mass and NMR spectroscopy. All three substances are substances related to methylprednisolone.en
dc.description.abstractU ovom radu ispitivane su osobine farmakološki aktivne supstance metilprednizolona (u obliku metilprednizolon-natrijum-sukcinata) u gotovom proizvodu - liofilizatu za rastvor za injekcije. Cilj rada je ispitivanje hemijske stabilnosti metilpredni-zolon-natrijum-sukcinata u dvokomornoj bočici, kao specifičnom sistemu kontaktnog pakovanja. Ispitan je efekat različitih parametara: temperature, vlage i svetlosti. Za određivanje koncentracije metilprednizolona, kao zbirne koncentracije metilprednizolon estara (17-hidrogen-sukcinata i 21-hidrogen-sukcinata) i slobodnog metilprednizolona, korišćena je metoda opisana u Američkoj farmakopeji. Za ispitivanje srodnih supstanci primenjena je HPLC metoda. Uočena su 4 degradaciona proizvoda. Dokazano je da povećanje temperature ima najveći značaj na proces degradacije i utiče na povećanje sadržaja nečistoća B, C i D, dok prisustvo svetlosti dovodi do povećanja sadržaja nečistoće A. Nečistoće B, C i D su identifikovane primenom masene i NMR spektroskopije. Sve tri nečistoće su identifikovane kao srodne supstance metilprednizolona.sr
dc.publisherSrpsko hemijsko društvo, Beograd
dc.relationinfo:eu-repo/grantAgreement/MESTD/MPN2006-2010/142072/RS//
dc.rightsopenAccess
dc.sourceJournal of the Serbian Chemical Society
dc.subjectmethylprednisolone sodium succinateen
dc.subjectfreeze-dried powderen
dc.subjectcontainer closure systemen
dc.subjectstabilityen
dc.subjectimpuritiesen
dc.titleMethylprednisolone and its related substances in freeze-dried powders for injectionsen
dc.titleMetilprednizolon i njegove srodne supstance u liofilizatu za rastvor za injekcijesr
dc.typearticle
dc.rights.licenseBY-NC-ND
dcterms.abstractСоломун, Љиљана; Вајс, Влатка; Вуцковић, Иван М.; Ибрић, Светлана; Вујић, Зорица; Метилпреднизолон и његове сродне супстанце у лиофилизату за раствор за ињекције; Метилпреднизолон и његове сродне супстанце у лиофилизату за раствор за ињекције;
dc.citation.volume75
dc.citation.issue10
dc.citation.spage1441
dc.citation.epage1452
dc.citation.other75(10): 1441-1452
dc.citation.rankM23
dc.identifier.wos000283895200013
dc.identifier.doi10.2298/JSC100115087S
dc.identifier.scopus2-s2.0-78449271200
dc.identifier.fulltexthttp://farfar.pharmacy.bg.ac.rs//bitstream/id/326/1424.pdf
dc.identifier.rcubconv_792
dc.type.versionpublishedVersion


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