Browse > Article

Simplified HPLC Method for the Determination of Mirtazapine in Human Plasma and Its Application to Single-dose Pharmacokinetics  

Gwak Hye-Sun (College of Pharmacy, Ewha Womans University)
Lee Na-Young (College of Pharmacy, Dongduk Womens University)
Chun In-Koo (College of Pharmacy, Dongduk Womens University)
Publication Information
Biomolecules & Therapeutics / v.14, no.1, 2006 , pp. 40-44 More about this Journal
Abstract
Mirtazapine is an antidepressant agent with dual action on both the noradrenergic and serotonergic neurotransmitter systems. A simple high performance liquid chromatographic method has been developed and validated for the quantitative determination of mirtazapine in human plasma. A reversed-phase Cl8 column was used for the determination of mirtazapine with a mobile phase composed of 0.01M ammonium acetate solution (pH 4.2) and acetonitrile (75:25, v/v%) at a flow rate of 1.2 mL/min. Terazosin hydrochloride was used as an internal standard. The fluorescence detector was set at excitation and emission wavelengths of 290 and 350 nm, respectively. Intra- and inter-day precision and accuracy were acceptable for all quality control samples including the lower limit of quantification of 3 ng/mL. Mirtazapine was stable in human plasma under various storage conditions. This method was used successfully for a pharmacokinetic study using plasma samples after oral administration of a single 30 mg dose as mirtazapine base to 8 healthy volunteers. The maximum plasma concentration of mirtazapine was $64.1{\pm}28.0ng/mL$ at 1.8 h, and the area under the curve and elimination half-life were calculated to be $674.1{\pm}218.5ng\;h/mL\;and\;23.4{\pm}3.8h$, respectively.
Keywords
Mirtazapine; terazosin hydrochloride; high performance liquid chromatography; pharmacokinetic study;
Citations & Related Records
연도 인용수 순위
  • Reference
1 Richou, H., Ruirny, P. and Charbaut, J. (1995). A multicenter, double- blind, clomipramine-controlled efficacy and safety study of Org 3770. Hum. Psychopharmacol. 10, 263-271   DOI
2 Smith, W.T., Glaudin, V., Panagides, J. and Gilvary, E. (1990). Mirtazapine vs. amitriptyline vs. placebo in the treatment of major depressive disorder. Psychopharmacol. Bull. 26, 191- 196
3 Bremner, J.D. (1995). A double-blind comparison of Org 3770, amitriptyline and placebo in major depression. J. Clin. Psychiatry. 56, 519-525
4 De Boer, T., Nefkens, F. and van Helvoirt, A. (1994). The alpha 2-adrenoceptor antagonist Org 3770 enhances serotonin transmission in vivo. Eur. J. Pharmacol. 253, R5-6   DOI
5 Food and Drug Administration, Guidance for Industry: Bioanalytical method validation, Center for Drug Evaluation and Research, Rockville, MD, 200l
6 Halakis, J.A. (1995). Org 3770 (mirtazapine) vs. trazodone: a placebo controlled trial in depressed elderly patients. Hum. Psychopharmacol. 10, S125-S133   DOI   ScienceOn
7 Marttila, M., Jaaskelainen, J., Jarvi, R. (1995). A double-blind study comparing the efficacy and tolerability of mirtazapine and doxepine in patients with major depression. Eur. Neuropsychopharmacol. 5, 441-446   DOI
8 Maris, F.A., Dingler, E. and Niehues, S. (1999). High-performance liquid chromatographic saay with fluorescence detection for the routine monitoring of the antidepressant mirtazapine and its demthyl metabolite in human plasma. J. Chromatogr. B 721, 309-316
9 Timmer, C.J., Paanakker, J.E. and Vries, M.V. (1997). Mirtazapine phannacokinetics with two dosage regimens and two pharmaceutical formulations. Pharm. Res. 14,98-102   DOI   ScienceOn
10 Mullin, J., Lodge, A. and Bennie, E. (1996). A multicenter, double- blind, amitriptyline-controlled study of mirtazapine in patients with major depression. J. Psychopharmacol. 10, 235-240   DOI   ScienceOn
11 Zivkov, M. and de Jongh, G. (1995). Org 3770 vs. amitriptyline: a 6-week randomized double-blind multicenter trial in hospitalized patients. Hum. Psychopharmacol. 10, 173-180   DOI   ScienceOn
12 Zivkov, M., Roes, K.C.B. and Polis, A.G. (1995). Efficacy of Org 3770 (mirtazapine) vs. amitriptyline in patients with major depressive disorder: a meta-analysis. Hum. Psychopharmacol. 10, S135-S145   DOI   ScienceOn
13 Paanakker, J.E. and Van Hal, H.J.M. (1987). Capillary gas chromatographic assay for the routine monitoring of the antidepressant mepirzepine in human plasma. J. Chromatogr. 417, 203-207   DOI   ScienceOn
14 Benkert, O., Muller, M. and Szegedi, A. (2002). An overview of the clinical efficacy of mirtazapine. Hum. Psychopharmacol. 17, S23-S26   DOI   ScienceOn
15 Kamas, H.T., Shiu, G. and Shah, V.P. (1991). Validation of bioanalytical methods. Pharm. Res. 8, 421-426   DOI