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Development and Validation of Sensitive Methods for Determination of Sibutramine Hydrochloride Monohydrate and Direct Enantiomeric Separation on a Protein-Based Chiral Stationary Phase

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Sibutramine hydrochloride monohydrate, chemically 1-(4-chlorophenyl)-N,N-dimethyl--(2-methylpropyl) hydrochloride monohydrate (SB.HCl.H2O), was approved by the U.S. Food and Drug Administration for the treatment of obesity. The objective of this study was to develop, validate, and compare methods using UV-derivative spectrophotometry (UVDS) and reversed-phase high-performance liquid chromatography (HPLC) for the determination of SB.HCl.H2O in pharmaceutical drug products. The UVDS and HPLC methods were found to be rapid, precise, and accurate. Statistically, there was no significant difference between the proposed UVDS and HPLC methods. The enantiomeric separation of SB was obtained on an alpha-1-acid glycoprotein column. The R- and S-sibutramine were eluted in <5 minwith baseline separation of the chromatographic peaks ( = 1.9 and resolution = 1.9).

Document Type: Research Article

Affiliations: 1: Universidade de So Paulo, Faculdade de Cincias Farmacuticas, Departamento de Farmcia, CP 66355, CEP: 05315-970, So PauloSP, Brazil. 2: Instituto Adolfo Lutz, Coordenao dos Institutos de Pesquisa, Av. Dr Arnaldo, 355, Cerqueira Csar 01246-902, So PauloSP, Brazil.

Publication date: May 1, 2008

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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 The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better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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