| Title: | Determination of topiramate in human plasma using liquid chromatography tandem mass spectrometry |
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| Authors: | ID Vnučec, Tanja (Author)
ID Cvitkovič-Maričič, Lea (Author)
ID Prosen, Helena (Author)
ID Brodnjak-Vončina, Darinka (Author) |
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| Files: |  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
 http://acta-arhiv.chem-soc.si/60/60-1-144.pdf
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| Language: | English |
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| Work type: | Scientific work |
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| Typology: | 1.01 - Original Scientific Article |
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| Organization: | FKKT - Faculty of Chemistry and Chemical Engineering
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| 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. |
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| Keywords: | topiramate, liquid chromatography tandem mass spectroscopy, human plasma, bioequivalence study |
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| Publication status: | Published |
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| Publication version: | Version of Record |
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| Year of publishing: | 2013 |
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| Number of pages: | str. 144-150 |
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| Numbering: | Letn. 60, št. 1 |
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| PID: | 20.500.12556/DKUM-58141  |
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| ISSN: | 1318-0207 |
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| UDC: | 543.544.5:543.51:615.07 |
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| ISSN on article: | 1318-0207 |
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| COBISS.SI-ID: | 36618757 |
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| NUK URN: | URN:SI:UM:DK:AXOJG6XP |
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| Publication date in DKUM: | 18.08.2017 |
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| Views: | 1609 |
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| Downloads: | 104 |
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| Metadata: |    |
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| Categories: | Misc.
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