a validated direct spectrofluorimetric method for quantification of mirtazapine in human whole blood验证直接spectrofluorimetric米氮平的方法量化人体全血.pdfVIP

Spectroscopy 24 (2010) 641–649 641 DOI 10.3233/SPE-2010-0488 IOS Press A validated direct spectrofluorimetric method for quantification of mirtazapine in human whole blood Balraj Saini, Manjula Kaushal and Gulshan Bansal ∗ Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, India Abstract. A spectrofluorimetric method for estimation of mirtazapine in human whole blood was developed and validated. The recovery efficiency of the processing method was 95–98%. The analytical method was linear over drug concentration of 10– 200 ng/ml. The limit of quantification was 10 ng/ml. The method was precise with %RSD for intra-day and inter-day precision being 3.0 and 1.5, respectively. Excellent recoveries (97.87–99.69%) were achieved during accuracy studies. The method was robust to small changes in processing method and instrumental parameters. The present method can be employed for direct fluorimetric determination of mirtazapine in human whole blood during clinical studies. Keywords: Mirtazapine, spectrofluorimetry, protein precipitation, human blood, validated 1. Introduction Mirtazapine is a piperazinoazepine-based tetracyclic compound which is used as an antidepressant in moderate to severe depression. It is classified as an adrenergic and specific serotonergic antide- pressant [21,24]. Chemically it is 1,2,3,4,10,14b-hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]-2- benzazepine which exists as a mixture of (−) and (+) enantiomers (Fig. 1) and both have similar phar- macological activity [1]. It acts by facilitating central serotonergic and nor-adrenergic transmission and antagonizes postsynaptic 5-HT2A , 5-HT3 and H1 receptors [8]. It is extensively metabolized in liver by cytochrome P450 isoenzymes to demethylated and hydroxylated metabolites which are pharmacologi- cally active [1]. Numerous sophisticate