Pharmacokinetics of doxazosin gastrointestinal therapeutic system after multiple administration in Korean healthy volunteers

Yoon Hee Kwon, Hye Sun Gwak, Sun Jung Yoon, In Koo Chun

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5 Scopus citations


Doxazosin mesylate is a selective alpha-adrenoreceptor antagonist for the treatment of hypertension and benign prostatic hyperplasia. A simple high performance liquid chromatographic method has been developed and validated for the quantitative determination of doxazosin in plasma. A reversed phase C18 column was used for the separation of doxazosin and prazosin (internal standard) with a mobile phase composed of water • acetonitrile • triethylamine (68:32:0.2 v/v, pH 5.0) at a flow rate of 1.2 mL/min. The fluorescence detector was operated at 246 (excitation) and 389 nm (emission). Intra- and inter-day precision and accuracy were acceptable for all quality control samples including the lower limit of quantification of 1 ng/mL. Recovery of doxazosin from human plasma was greater than 93.4%. Doxazosin was stable in human plasma under various storage conditions. This method was used successfully for a pharmacokinetic study in plasma after oral administration of multiple 4-mg dose of doxazosin gastrointestinal therapeutic system formulation to 16 healthy volunteers. At steady state the mean area under the curve for a dosing interval and elimination half-life were calculated to be 367.0 ± 63.5 ng·hr/mL and 29.2 ± 4.5 hr, respectively. There was no difference in pharmacokinetic parameters between male and female.

Original languageEnglish
Pages (from-to)824-829
Number of pages6
JournalDrug Development and Industrial Pharmacy
Issue number8
StatePublished - Aug 2007

Bibliographical note

Funding Information:
This study was supported by Grant KFDA-05132-EQI-213 from Korea Food and Dug Administration.


  • Doxazosin gastrointestinal therapeutic system
  • High-performance liquid chromatography
  • Pharmacokinetic parameters
  • Prazosin


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