Amiodarone and Desethylamiodarone in Serum/Plasma - HPLC

Order No.: 25000, for 100 tests
Amiodarone, Desethylamiodarone

Analysis of active metabolite included
Quick and easy sample preparation
Stable calibration standards and controls

CE-IVD validated product ready for IVDR within timeframes and transition periods specified by the IVDR-2022 regulation



Clinical relevance

Amiodarone is a typical representative of the class III antiarrhythmic agents that induce prolongation of the action potentials and refractory periods in the heart. It is approved in Germany for the treatment of various tachycardia arrhythmias, and is often prescribed in combination with other beta blockers. Additionally, amiodarone is often prescribed when other medications show no effect or stop working. Although amiodarone itself rarely causes cardiac arrhythmias, adverse effects may occur in other organs, e.g. reversible sensitivity to light in the eyes and the skin with risk of sunburn, increased liver-related values, as well as very rarely lung damages and hyperthyroidism/hypothyroidism. Regular monitoring of the amiodarone levels is therefore essential. Its bioactive metabolite desethylamiodarone can also be used for measurements.


Product advantages

  • Metabolite analysis included
  • Simple and fast sample preparation
  • Stable internal standards and quality controls

This assay allows for the simple and reliable HPLC analysis of amiodarone and desethylamiodarone. Sample preparation is based on a simple and very efficient method of precipitation of all of the interfering components of the sample matrix. The separation is then performed on an isocratic HPLC system with UV detector.

The MassTox® TDM Series A Parameter Set for Antiarrhythmic Drugs is also available for using LC-MS/MS to analyse amiodarone and desethylamiodarone.

More Information
Method of Analysis HPLC
Number of Tests 100
Please note The freely available information on this website, in particular on the sample preparation, are not sufficient to work with our products. Please read instructions and warning notices on products and/or instruction manuals.
Lower Limit of Quantification

0.15 mg/l (Amiodarone)
0.10 mg/l (Desethylamiodarone)

Upper Limit of Quantification

up to 20 mg/l

Recovery 99–106 %

CV = 0.6–1.1 %


CV = 3.4–5.5 %

Run Time approx. 11 min
Specimen Serum/Plasma
Pre-analytic Treatment

Patient samples are stable cooled (+4 °C) in the dark for at least 24 hours. For longer storage keep samples at approx. -20 °C.


Sample Preparation
  • Pipette 100 µl serum/plasma
    + 150 µl Internal Standard
    + 100 µl Precipitation Reagent into an amber coloured reaction vial (light protection).
  • Mix 20 s (vortex).
  • Centrifuge 10 min at at least 9000 x g.
  • Inject 25 µl of the supernatant into the HPLC system.
Sample Stability Protected from light, the prepared samples are stable at +20 to +25 °C for up to 1 week, at +2 to +8 °C or below -18 °C for up to 2 weeks.
Injection Volume 25 µl
Flow Rate 1 ml/min
Column Temperature ambient (~ 25 °C)
Wavelength 242 nm
Gradient isocratic
Additional Info

Any isocratic HPLC system with UV detector is suitable.

Parameter Amiodarone, Desethylamiodarone
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