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HPLC with Diode-Array Detection for Determination of Leflunomide in Tablets
Authors:D. S. Miron  C. Soldattelli  E. E. S. Schapoval
Affiliation:1. Programa de Pós-gradua??o em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil
2. Departamento de Produ??o e Controle de Medicamentos, Faculdade de Farmácia, Universidade do Rio Grande do Sul, Porto Alegre, RS, Brazil
Abstract:We have developed and validated a simple HPLC method for analysis of leflunomide in tablets. Method conditions were determined by assay of a photodegraded sample of leflunomide. Optimum chromatographic performance was obtained with a C18 column and acetonitrile-water as mobile phase. Comparison of spectra recorded with a diode-array detector during elution of the leflunomide peak enabled determination of method specificity. The method is highly sensitive (detection limit 10 ng mL?1) and robust to deliberate variation of the conditions (RSD of peak area < 2.0%). Precision and accuracy were adequate over the concentration range 10 to 100 µg mL?1. These results show the proposed method is suitable for its intended use.
Keywords:Column liquid chromatography  Diode-array detection  Leflunomide
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