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Validated Stability-Indicating RP-HPLC Method for the Determination of Rimonabant in a Pharmaceutical Dosage Form

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A simple RP-HPLC method was developed and validated for the determination of rimonabant in a pharmaceutical dosage form. The separation was performed on a C18 column (150 4.6 mm id, 5 m) with acetonitrilewater (75 + 25, v/v) mobile phase. The detection was achieved with a diode array detector at 215 nm. The method was linear in the concentration range of 0.550 g/mL (r = 1) with an LOQ of 0.24 g/mL. The specificity and stability-indicating capability of the method were proved through forced degradation studies, and it was shown that there was no increase of the cytotoxicity. Rimonabant was exposed to hydrolytic, oxidative, and photolytic stress conditions, and the samples were analyzed by the proposed method. Under optimized conditions, rimonabant was successfully separated from its degradation products within 10 min, and the resolution was found to be greater than 2. The RSD values for intraday and interday precision were always less than 2. Interday accuracy ranged from 98.1 to 101.7 (RSD = 1.0). Moreover, method validation demonstrated acceptable results for sensitivity and robustness. The method was applied for the quantitative analysis of rimonabant in a tablet dosage form to demonstrate its use for improving the QC of pharmaceuticals containing this drug.
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Document Type: Research Article

Affiliations: Universidade Federal de Santa Maria, Departamento de Farmcia Industrial and Programa de Ps-Graduao em Cincias Farmacuticas, Centro de Cincias da Sade, Santa Maria, RS, Brazil.

Publication date: May 1, 2010

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 The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory;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