20.500.12556/DKUM-58141 Determination of topiramate in human plasma using liquid chromatography tandem mass spectrometry The LC-MS/MS method for determination of the anti-epileptic drug topiramate (TPM) in human plasma was developed and validated for pharmacokinetic and bioequivalence study purposes. For quantitative determination of TPM values the method with deuterated internal standard (topiramate-d12) and liquid chromatography with tandem mass spectrometry was used. TPM was extracted from the human plasma using the solid-phase extraction procedure on a Strata X extraction column. Negative ions were monitored in the selected reaction monitoring mode (SRM) and transitions m/z 338.2 > 78.2 and m/z 350.3 > 78.2 were used for the quantitative evaluation of TPM and the internal standard, respectively. The results obtained from validation were statistically evaluated according to the requirements of European Medicines Agency (EMA) and Food and Drug Administration (FDA) regulatory guidelines. The linearity of the method was checked within a concentration range from 10 to 2000 ng/mL. Successful validation confirmed that this method is precise, accurate, sensitive and therefore suitable for determination of topiramate plasma levels in pharmacokinetic and bioequivalence studies. Razvili in validirali smo LC-MS/MS metodo za določevanje antiepileptičnega zdravila topiramat (TPM) v humani plazmi za namene študij farmakokinetike in bioekvivalence. Za kvantitativno določitev smo uporabili metodo devteriranega internega standarda (topiramat-d12) in tekočinsko kromatografijo s tandemsko masno spektrometrijo. Učinkovino TPM smo ekstrahirali iz humane plazme z ekstrakcijo na trdnem nosilcu na Strata X ekstrakcijskih kolonah. Spojine smo ionizirali z elektrorazprševanjem in merjenjem negativnih ionov, spremljali smo SRM prehoda 338,2 > 78,2 za TPM in 350,3 > 78,2 za interni standard. Rezultate vsebnosti topiramata smo statistično ovrednotili v skladu z zahtevami EMA regulative in FDA smernicami. Linearnost metode smo preverili v koncentracijskem območju od 10 do 2000 ng/ml. Uspešni rezultati testov so pokazali, da je razvita metoda natančna, točna in občutljiva ter primerna za določanje topiramata v humani plazmi v študijah farmakokinetike in bioekvivalence. topiramate liquid chromatography tandem mass spectroscopy human plasma bioequivalence study analizna kemija farmakologija farmakokinetične študije bioekvivalentna študija analitske metode kromatografska analiza spektralna analiza tekočinska kromatografija s tandemsko masno spektrometrijo LC-MS/MS validacija suha lisa krvi antiepileptična zdravila topiramat true false true Angleški jezik Slovenski jezik Znanstveno delo 2016-04-08 16:41:16 2017-08-18 09:39:12 2022-06-16 03:07:07 2019-07-11 10:29:51 2013 0 0 str. 144-150 št. 1 Letn. 60 2013 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 1318-0207 543.544.5:543.51:615.07 14086149 36618757 1318-0207 URN:SI:UM:DK:AXOJG6XP Acta_Chimica_Slovenica_2013_Popov_et_al._Determination_of_topiramate_in_human_plasma_using_liquid_chromatography_tandem_mass_spectrometr.pdf Acta_Chimica_Slovenica_2013_Popov_et_al._Determination_of_topiramate_in_human_plasma_using_liquid_chromatography_tandem_mass_spectrometr.pdf 1 2BCBAE1A3F84F1CB92F1331CAC98A245 d841b36874c2eedf49a5f172f4ba0fa776c27a62ed93b067ab409a7d2d8393d3 86ca459c-7c0e-11eb-bb7a-00155d0001ca https://dk.um.si/Dokument.php?lang=slv&id=115493 http://acta-arhiv.chem-soc.si/60/60-1-144.pdf 1 https://dk.um.si/Dokument.php?lang=slv&id=88222 Fakulteta za kemijo in kemijsko tehnologijo 0 0 0