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Development and Validation of a Liquid Chromatographic Method for Fexofenadine Hydrochloride in Capsules

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Abstract:

This paper describes the development and validation of a new, simple, fast, and sensitive liquid chromatographic method for the determination of the antihistamine fexofenadine. Although widely used in the treatment of allergic diseases, fexofenadine is not listed in any pharmacopeia, and there are few methods in the literature for its quantitation in pharmaceutical dosage forms. In this work, a LiChrospher® 100 RP-18 (250 × 4.0 mm, 5 μm) column was used as the stationary phase, and acetonitrile–5mM ammonium acetate buffer (50 + 50, v/v) at pH 3.2 was the mobile phase. Through the evaluation of the analytical parameters, it was shown that the method is linear (r = 0.9999) at concentrations ranging from 20.0 to 80.0 μg/mL, precise (intraday relative standard deviation [RSD] values = 0.85, 0.40, and 0.81%; interday RSD = 0.77%), accurate (mean recovery = 99.05%), specific, and robust. The detection and quantitation limits are 0.3409 and 1.033 μg/mL, respectively. These low values show the good sensitivity of the proposed method.

Document Type: Research Article

Affiliations: Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia, Programa de Pós-Graduação em Ciências Farmacêuticas, Av. Ipiranga, 2752, Lab. 402, Porto Alegre-RS, CEP 90610-000, Brazil.

Publication date: 2004-09-01

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 The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory;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