Resumo

QUINONES-GARCIA, Yaidel A; CALVO-ALONSO, Amalia M; CARABALLOSO-NOA, Isabel M  e  ALONSO-RODRIGUEZ, Heidy L. Reverse phase High Performance Liquid Chromatogray (HPLC) determination of a monobrominated impurity in Dermofural. Method Validation. Rev Cub Quim [online]. 2015, vol.27, n.2, pp.163-181. ISSN 2224-5421.

Dermofural is a topical ointment based on the active pharmaceutical ingredient furvina (2-bromo-5-(2-bromo-2-nitrovinyl) furan), which exhibit antibacterial and antifungal action. This product contains a known monobrominated impurity (2-bromo-5-(2-nitrovinyl) furan) which has to be determined among the quality specifications for the end product. This paper describes the validation of a Reverse Phase High Performance Liquid Chromatography method to quantify this impurity in Dermofural samples. The validation study was carried out as established by the "Centro para el Control Estatal de la Calidad de los Medicamentos". System suitability, specificity, linearity, precision, accuracy, range and detection and quantification limits were evaluated. The analytical method demonstrated to be specific, linear, accurate and precise, with limits of detection and quantification of 0,1 mg/L and 0,09 mg/L, respectively, therefore it can be used in quality control and stability studies of Dermofural.

Palavras-chave : dermofural; furvina; validation.

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