DETERMINATION OF MIANSERIN IN BIOLOGICAL MATERIAL BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Abstract

Introduction. Mianserin is a derivative of tetracyclic antidepressants, belongs to the piperazine-azepine derivatives. Chemically, it is (±)-2-methyl-1,2,3,4,10,14b-hexahydrodibenzo[c,f]pyrazino[1,2-a]azepine. Mianserin exhibits anti-stress activity, which is very important in the treatment of patients with depression that is combined with anxiety. The aim of the study – development of an effective technique for isolating mianserin from biological tissues and selecting optimal conditions for determination by HPLC in the presence of metabolites. Research Methods. Identification and quantification of mianserin isolated from biological material was performed by HPLC. The research was carried out on an Agilent 1200 liquid chromatograph, an Eclips C18 column, 150,0 mm long, 4,6 mm in diameter, and the sorbent particle size was 5 μm. The sample was injected into the chromatograph in the isocratic mode, the volume of the injected sample was 20 μl, the column temperature was 25 °C. A comparative evaluation of the efficiency of isolation of mianserin was performed from model liver samples acidified with 30 % acetic acid. Results and Discussion. During the study of rat liver extracts simultaneously with the peak of mianserin (retention time of 3.37 min), the peak of the metabolite of mianserin, identified by us as demethylmianserin – M-7 (retention time of 2.52 min.) is recorded. Conclusions. The efficiency of isolation of mianserin from model liver samples by two methods was compared. It was established that 28.9–33.6 % of mianserin is isolated with water acidified with oxalic acid. 56.5–59.8 % of the studied drug can be isolated with an acidified 30 % solution of acetic acid. To prepare the sample for analysis by HPLC, the conditions for their purification were worked out, the degree of extraction of mianserin from the studied sample is 99.8–100.0 %. Developed conditions for identification and quantification of mianserin by HPLC on an Eclips C18 column and detection at a wavelength of 214 nm. The limit of quantitative determination of mianserin in solutions is 0.5 μg/ml.