20.500.12556/DKUM-38546 VALIDACIJA HPLC METODE ZA KONTROLO KVALITETE INTERMEDIATA PRI SINTEZI TELMISARTANA VALIDATION OF HPLC METHOD FOR QUALITY CONTROL OF INTERMEDIATE USED IN THE SYNTHESIS OF TELMISARTON Za vsako novo razvito analizno metodo je potrebno dokazati ali je metoda ustrezna za ločevanje komponent nekega vzorca ter da daje zanesljive rezultate. To dokažemo z ovrednotenjem oziroma validacijo same analizne metode. Proces validacije zajema določitev validacijskih parametrov z izdelavo validacijskega načrta. Sledi eksperimentalna izvedba validacije ter ovrednotenje pridobljenih rezultatov s pomočjo statističnih metod. Za kontrolo kvalitete intermediata pri sintezi aktivne učinkovine Telmisartan je bila razvita nova metoda. Namenjena je določanju sorodnih substanc in kromatografske čistote prej omenjenega intermediata. S pomočjo postavljenih parametrov smo skušali ugotoviti ali je postavljena analizna metoda selektivna, linearna in robustna ter da daje pravilne in natančne rezultate. Določili smo tudi mejo zaznavnosti in mejo določljivosti analizne metode ter stabilnost analizne raztopine. Na podlagi vseh pridobljenih rezultatov glede na predpisane parametre smo dokazali, da je postavljena analizna metoda ustrezna za določanje sorodnih substanc in kromatografske čistosti intermediata pri sintezi Telmisartana. For each newly developed analytical method it is required to demonstrate that the method is suitable for separating components of a sample and that it gives reliable results. This can be proved by evaluation or validation of analytical method. Validation process includes determination of validation parameters for the preparation of validation plan. After the validation plan an experimental part of the validation is performed and results obtained are evaluated using statistical methods. For the purpose of quality control of the intermediate in the synthesis of the active substance Telmisartan a new analytical method was developed. The method is intended for the determination of related substances and chromatographic purity of the aforementioned intermediate. Using the set parameters we were trying to prove that the set analytical method is selective, linear, robust and that it gives accurate and precise results. We have also determined the limit of detection and limit of quantitation of the analytical method and stability of the analytical solution. On the basis of results obtained according to the prescribed parameters, we have proved that the set analytical method is suitable for the determination of related substances and chromatographic purity of an intermediate in the synthesis of Telmisartan. Intermediat kromatografija HPLC dobra laboratorijska praksa DLP intermediate chromatography HPLC good manufacturing pratice GMP true true false [S. Zupančič] Slovenski jezik Angleški jezik Diplomsko delo 2012-10-01 13:34:27 2012-10-05 09:35:27 2022-05-04 13:22:45 2021-04-19 03:21:34 2012 0 Maribor 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 543.444.5.068.7:544.431.24(043.2) 16701206 URN:SI:UM:DK:J3HRFPXO VS_Zupancic_Sandra_2012.pdf VS_Zupancic_Sandra_2012.pdf 1 8D4BE06AD510B280EA9B5C9271041141 5c3f57368df953e2cb294633c82a2757c7258e87908a96006b2d44a4cf853eed 81d48f19-7c08-11eb-bb7a-00155d0001ca 20.500.12556/dkum/c8082fea-5ff3-40e7-9e02-1e22cf212cbd https://dk.um.si/Dokument.php?lang=slv&id=51568 Fakulteta za kemijo in kemijsko tehnologijo 0 0 0