Determination of Candesartan in Human Plasma using Liquid Chromatography - Tandem Mass Spectrometry

A sensitive, specific and rapid liquid chromatography - tandem mass spectrometry method was developed and validated for the determination of candesartan in human plasma. Analyte was separated from endogenous components present in plasma by solid phase extraction. Chromatographic separation was perfo...

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Main Authors: Vanja Forjan, Lea Cvitkovič Maričič, Helena Prosen, Darinka Brodnjak Vončina
Format: Article
Language:English
Published: Slovenian Chemical Society 2016-02-01
Series:Acta Chimica Slovenica
Subjects:
Online Access:https://journals.matheo.si/index.php/ACSi/article/view/1836
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author Vanja Forjan
Lea Cvitkovič Maričič
Helena Prosen
Darinka Brodnjak Vončina
author_facet Vanja Forjan
Lea Cvitkovič Maričič
Helena Prosen
Darinka Brodnjak Vončina
author_sort Vanja Forjan
collection DOAJ
description A sensitive, specific and rapid liquid chromatography - tandem mass spectrometry method was developed and validated for the determination of candesartan in human plasma. Analyte was separated from endogenous components present in plasma by solid phase extraction. Chromatographic separation was performed on Gemini C18 analytical column using mobile phase acetonitrile – 5 mM ammonium formate pH 2 (90:10, v/v) at flow rate of 0.3 mL/min. For detection, tandem mass spectrometry in SRM mode with positive electrospray ionization was used. The mass transitions m/z 441.1 > 263.1 and 445.1 > 267.1 were used to determine candesartan by using candesartan-d4 as an internal standard. After development, the method was validated according to the requirements of EMA regulatory guidelines in the concentration range 1 - 400 ng/ml in human plasma. Limit of quantification (LLOQ) was 1 ng/ml. The developed and validated method proved to be very fast and reproducible and was therefore successfully implemented in pharmacokinetic and bioequivalence studies with large number of study samples.
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spelling doaj.art-e8b92b6401a14554932104a11ad15a162022-12-21T19:10:45ZengSlovenian Chemical SocietyActa Chimica Slovenica1318-02071580-31552016-02-01631384610.17344/acsi.2015.1836334Determination of Candesartan in Human Plasma using Liquid Chromatography - Tandem Mass SpectrometryVanja Forjan0Lea Cvitkovič Maričič1Helena Prosen2Darinka Brodnjak Vončina3"Krka d.d. Novo mesto""Krka d.d. Novo mesto"University of Ljubljana, Faculty of Chemistry and Chemical Technology, Večna pot 113, 1000 Ljubljana, SloveniaUniversity of Maribor, Faculty of Chemistry and Chemical Engineering, Smetanova 17, SI-2000 Maribor, SloveniaA sensitive, specific and rapid liquid chromatography - tandem mass spectrometry method was developed and validated for the determination of candesartan in human plasma. Analyte was separated from endogenous components present in plasma by solid phase extraction. Chromatographic separation was performed on Gemini C18 analytical column using mobile phase acetonitrile – 5 mM ammonium formate pH 2 (90:10, v/v) at flow rate of 0.3 mL/min. For detection, tandem mass spectrometry in SRM mode with positive electrospray ionization was used. The mass transitions m/z 441.1 > 263.1 and 445.1 > 267.1 were used to determine candesartan by using candesartan-d4 as an internal standard. After development, the method was validated according to the requirements of EMA regulatory guidelines in the concentration range 1 - 400 ng/ml in human plasma. Limit of quantification (LLOQ) was 1 ng/ml. The developed and validated method proved to be very fast and reproducible and was therefore successfully implemented in pharmacokinetic and bioequivalence studies with large number of study samples.https://journals.matheo.si/index.php/ACSi/article/view/1836candesartanliquid chromatography - tandem mass spectrometryhuman plasmabioequivalence study
spellingShingle Vanja Forjan
Lea Cvitkovič Maričič
Helena Prosen
Darinka Brodnjak Vončina
Determination of Candesartan in Human Plasma using Liquid Chromatography - Tandem Mass Spectrometry
Acta Chimica Slovenica
candesartan
liquid chromatography - tandem mass spectrometry
human plasma
bioequivalence study
title Determination of Candesartan in Human Plasma using Liquid Chromatography - Tandem Mass Spectrometry
title_full Determination of Candesartan in Human Plasma using Liquid Chromatography - Tandem Mass Spectrometry
title_fullStr Determination of Candesartan in Human Plasma using Liquid Chromatography - Tandem Mass Spectrometry
title_full_unstemmed Determination of Candesartan in Human Plasma using Liquid Chromatography - Tandem Mass Spectrometry
title_short Determination of Candesartan in Human Plasma using Liquid Chromatography - Tandem Mass Spectrometry
title_sort determination of candesartan in human plasma using liquid chromatography tandem mass spectrometry
topic candesartan
liquid chromatography - tandem mass spectrometry
human plasma
bioequivalence study
url https://journals.matheo.si/index.php/ACSi/article/view/1836
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