Development and validation of the HPLC method for determination of vildagliptin content and impurities

6533b822fe1ef96bd127db63

RESEARCH PRODUCT

Development and validation of the HPLC method for determination of vildagliptin content and impurities

subject

VALIDĀCIJA AEŠH VILDAGLIPTĪNS DEGRADĀCIJA PIEMAISĪJUMI Ķīmija

description

Vildagliptīna satura un blakuspiemaisījumu satura noteikšanas AEŠH metodes izstrāde un validācija. Paškova O., zinātniskie vadītāji Dr. Chem. Bolotin A., Dr. Chem. Mekšs P., Maģistra darbs, 86 lappuses, 34 attēli, 52 tabulas, 26 literatūras avoti, 4 pielikumi. Latviešu valodā. Vildagliptīns ir jaunas klases antidiabētiskais preparāts. Katrai AFV jāzin tās saturs un piemaisījumu daudzums, jo no tā ir atkarīga medikamenta iedarbība. Darbā tika izstrādātas AEŠH/UV metodes pamatvielas satura un piemaisījumu satura noteikšanai vildagliptīnā, kā arī tika veikta šo metožu validācija. Darbā tika pieradīts, ka metodes lineāras, precīzas, pareizas un robustas, noteiktas detektēšanas un kvantitatīvās noteikšanas robežas zināmiem piemaisījumiem un pārbaudīta standartšķīdumu un analizējamo šķīdumu stabilitāte līdz 48 stundām. Darba ietvaros ir veikti arī vildagliptīna degradācijas pētījumi. Darbā iegūtās hromatogrammas tika apstrādātas Empower un ChemStation datorprogrammās un analīžu rezultātu dati tika apkopoti un apstrādāti MS Excel datorprogrammā. Analīzes metodes ļauj atdalīt visus zināmos un nezināmos piemaisījumus, kā arī degradācijas produktus no pamatvielas. Metodi var veiksmīgi pielietot rutīnas analīžu veikšanai.

year	journal	country	edition	language
2015-01-01

https://dspace.lu.lv/dspace/handle/7/29428

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