Development and Validation of a High Performance Liquid Chromatographic Method for the Determination of Voriconazole Content in Tablets |
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Authors: | A I H Adams A M Bergold |
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Institution: | 1. Programa de Pós-Gradua??o em Ciências Farmacêuticas, Facultade de Farmácia, UFRGS, Porto Alegre, Rio Grande do Sul, Brasil 2. Universidade de Passo Fundo, Rio Grande do sul, Brasil
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Abstract: | This paper describes the validation of an isocratic HPLC method for the assay of voriconazole in tablets. The method employs a Merck LiChrospher® 100 RP-8 (125 × 4.6 mm I.D., 5 µm particle size) column, with a mobile phase of methanol : triethylamine solutions 0.6 %, pH 6.0 (50:50, v/v) and UV detection at 255 nm. A linear response (r > 0.9999) was observed in the range of 20.0–100.0 µg mL?1. The method showed good recoveries (average 100.4%) and the relative standard deviation intra and inter-day were ≤ 1.0 %. Validation parameters as specificity and robustness were also determined. The method can be used for both quality control assay of voriconazole in tablets and for stability studies as the method separates voriconazole from its degradation products and tablet excipients. |
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Keywords: | Column liquid chromatography Antifungal agents Voriconazole assay Voriconazole tablets Quality control |
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