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Determination of New Antidepressants in Pharmaceuticals by Thin-Layer Chromatography with Densitometry

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A new and simple TLC-densitometry method has been developed for the simultaneous separation of the two noradrenergic and specific serotonergic antidepressants mirtazapine and mianserine and validated for their determination in commercially available tablets. The method used TLC plates precoated with silica gel 60F254 as the stationary phase, and the mobile phase consisted of hexaneisopropanol25 ammonia (70 + 25 + 5, v/v/v). Densitometric analysis was carried out in the absorbance mode at 280 nm. The method was validated in accordance with International Conference on Harmonization guidelines in terms of linearity, LOD, LOQ, precision, and accuracy. Calibration curves were linear (R2 > 0.9970) with respect to peak area in the concentration range of 5002500 and 5005000 ng/spot for mirtazapine and mianserine, respectively. The LODs were 20 and 35 ng/spot for mirtazapine and mianserine, respectively. The described method was successfully applied to the determination of mirtazapine and mianserine in their pharmaceutical formulations with recovery ranging from 99.83 to 101.20 of the labeled amount of the compounds. The proposed method can be used in routine QC of these drugs in pharmaceutical formulations.
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Document Type: Research Article

Affiliations: P.J. afrik University, Faculty of Science, Department of Analytical Chemistry, Moyzesova 11, SK-040 01 Koice, Slovak Republic.

Publication date: May 1, 2010

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  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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