Cover Image

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

Vanja Forjan, Lea Cvitkovič Maričič, Helena Prosen, Darinka Brodnjak Vončina

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; bioequivalence study

Full Text:

PDF


DOI: http://dx.doi.org/10.17344/acsi.2015.1836

Refbacks

  • There are currently no refbacks.


Copyright (c) 2016 Vanja Forjan, Lea Cvitkovič Maričič, Helena Prosen, Darinka Brodnjak Vončina

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.