Article ID Journal Published Year Pages File Type
1223023 Journal of Pharmaceutical and Biomedical Analysis 2008 6 Pages PDF
Abstract

This study aims to develop a standard protocol for the bioequivalence study of mianserin hydrochloride tablets—a tetracyclic antidepressant drug. For this purpose, a rapid, convenient and selective method using high performance liquid chromatography coupled with electrospray ionization mass spectrometry (HPLC–ESI/MS) has been developed and validated to determine mianserin in human plasma. Mianserin and the internal standard (I.S.), cinnarizine were extracted from plasma by N-hexane:dimethylcarbinol (98:2, v/v) after alkalinized with sodium hydroxide. LC separation was performed on a Thermo Hypersil-Hypurity C18 (5 μm, 150 mm × 2.1 mm) with the mobile phase consisting of 10 mM ammonium acetate (pH 3.4)–methanol–acetonitrile (35:50:15, v/v/v) at 0.22 ml/min. The retention time of mianserin and cinnarizine was 3.4 and 2.1 min, respectively. Quadrupole MS detection and quantitation was done by monitoring at m/z 265 [M+H]+ for mianserin and m/z 369 [M+H]+ for cinnarizine. The method was validated over the concentration ranges of 1.0–200.0 ng/ml for mianserin. The recovery was 81.3–84.1%, intra- and inter-day precision of the assay at three concentrations were 9.6–11.4% with accuracy of 97.5–101.2% and the lower limit of quantitation (LLOQ) detection was 1.0 ng/ml for mianserin. The stability of compounds was established in a battery of stability studies, i.e., short-term and long-term storage stability as well as freeze–thaw cycles. This method proved to be suitable for the bioequivalence study of mianserin hydrochloride tablets in healthy human male volunteers.

Related Topics
Physical Sciences and Engineering Chemistry Analytical Chemistry
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