Abstract
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 language | English |
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Pages (from-to) | 824-829 |
Number of pages | 6 |
Journal | Drug Development and Industrial Pharmacy |
Volume | 33 |
Issue number | 8 |
DOIs | |
State | Published - Aug 2007 |
Bibliographical note
Funding Information:This study was supported by Grant KFDA-05132-EQI-213 from Korea Food and Dug Administration.
Keywords
- Doxazosin gastrointestinal therapeutic system
- High-performance liquid chromatography
- Pharmacokinetic parameters
- Prazosin