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Title:Determination of topiramate in human plasma using liquid chromatography tandem mass spectrometry
Authors:ID Vnučec, Tanja (Author)
ID Cvitkovič-Maričič, Lea (Author)
ID Prosen, Helena (Author)
ID Brodnjak-Vončina, Darinka (Author)
Files:.pdf Acta_Chimica_Slovenica_2013_Popov_et_al._Determination_of_topiramate_in_human_plasma_using_liquid_chromatography_tandem_mass_spectrometr.pdf (189,19 KB)
MD5: 2BCBAE1A3F84F1CB92F1331CAC98A245
 
URL http://acta-arhiv.chem-soc.si/60/60-1-144.pdf
 
Language:English
Work type:Scientific work
Typology:1.01 - Original Scientific Article
Organization:FKKT - Faculty of Chemistry and Chemical Engineering
Abstract: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.
Keywords:topiramate, liquid chromatography tandem mass spectroscopy, human plasma, bioequivalence study
Publication status:Published
Publication version:Version of Record
Year of publishing:2013
Number of pages:str. 144-150
Numbering:Letn. 60, št. 1
PID:20.500.12556/DKUM-58141 New window
ISSN:1318-0207
UDC:543.544.5:543.51:615.07
ISSN on article:1318-0207
COBISS.SI-ID:36618757 New window
NUK URN:URN:SI:UM:DK:AXOJG6XP
Publication date in DKUM:18.08.2017
Views:1495
Downloads:98
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Categories:Misc.
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Record is a part of a journal

Title:Acta Chimica Slovenica
Shortened title:Acta Chim. Slov.
Publisher:Slovensko kemijsko društvo
ISSN:1318-0207
COBISS.SI-ID:14086149 New window

Licences

License:CC BY 4.0, Creative Commons Attribution 4.0 International
Link:http://creativecommons.org/licenses/by/4.0/
Description:This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.
Licensing start date:08.04.2016

Secondary language

Language:Slovenian
Abstract: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.
Keywords: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


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