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Title:Determination of candesartan in human plasma with liquid chromatography - tandem mass spectrometry
Authors:ID Forjan, Vanja (Author)
ID Cvitkovič-Maričič, Lea (Author)
ID Prosen, Helena (Author)
ID Brodnjak-Vončina, Darinka (Author)
Files:.pdf Acta_Chimica_Slovenica_2016_Forjan_et_al._Determination_of_Candesartan_in_Human_Plasma_with_Liquid_Chromatography_–_Tandem_Mass_Spectrom.pdf (215,54 KB)
MD5: F89C8825CD8F11ED00C83A48B440704B
PID: 20.500.12556/dkum/669046f0-c2ff-4629-afeb-8268dc8968a0
 
URL https://journals.matheo.si/index.php/ACSi/article/view/1836
 
Language:English
Work type:Scientific work
Typology:1.01 - Original Scientific Article
Organization:FKKT - Faculty of Chemistry and Chemical Engineering
Abstract: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.
Keywords:candesartan, liquid chromatography, tandem mass spectrometry, human plasma
Publication status:Published
Publication version:Version of Record
Year of publishing:2016
Number of pages:str. 38-46
Numbering:Letn. 63, št. 1
PID:20.500.12556/DKUM-67425 New window
ISSN:1318-0207
UDC:543.544.5
ISSN on article:1318-0207
COBISS.SI-ID:1536821699 New window
DOI:10.17344/acsi.2015.1836 New window
NUK URN:URN:SI:UM:DK:QC9RBESG
Publication date in DKUM:17.08.2017
Views:1459
Downloads:380
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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:17.08.2017

Secondary language

Language:Slovenian
Abstract:Za določevanje kandesartana v humani plazmi smo razvili in validirali LC-MS/MS metodo in dokazali, da je selektivna, občutljiva in ponovljiva. Za pripravo plazemskih vzorcev smo uporabili ekstrakcijo na trdni fazi. Za kromatografsko separacijo smo uporabili kolono Gemini C18 z mobilno fazo acetonitril – 5 mM amonijev formiat (90:10, v/v) pri pretoku 0,3 ml/min. Za detekcijo smo uporabili tandemsko masno spektrometrijo v SRM načinu z uporabo pozitivne ionizacije z elektro razprševanjem. Uporabljeni so bili masni prehodi: za kandesartan m/z 443,1 > 263,1 in za kandesartan-d4 kot interni standard 445,5 > 267,1. Po končanem razvoju smo metodo validirali v koncentracijskem območju 1–400 ng/ml v vzorcih humane plazme. Spodnja meja kvantitativne določitve je bila 1 ng/ml. Razvita in validirana metoda se je izkazala za zelo učinkovito pri farmakokinetičnih študijah.
Keywords:kandesartan, tekočinska kromatografija, tandemska masna spektrometrija, človeška plazma


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