Reverse phase High Performance Liquid Chromatogray (HPLC) determination of a monobrominated impurity in Dermofural. Method Validation

Authors

  • MSc. Yaidel A. Quiñones-García Centro de Bioactivos Químicos, Universidad Central “Marta Abreu” de Las Villas, Villa Clara
  • MSc. Amalia M. Calvo-Alonso Centro de Bioactivos Químicos, Universidad Central “Marta Abreu” de Las Villas, Villa Clara
  • Lic. Isabel M. Caraballoso-Noa Centro de Bioactivos Químicos, Universidad Central “Marta Abreu” de Las Villas, Villa Clara
  • Lic. Heidy L. Alonso-Rodríguez Centro de Bioactivos Químicos, Universidad Central “Marta Abreu” de Las Villas, Villa Clara

Abstract

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.

Keywords: dermofural, furvina, validation.

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Published

2015-10-30

How to Cite

Quiñones-García, M. Y. A., Calvo-Alonso, M. A. M., Caraballoso-Noa, L. I. . M., & Alonso-Rodríguez, L. H. L. (2015). Reverse phase High Performance Liquid Chromatogray (HPLC) determination of a monobrominated impurity in Dermofural. Method Validation. Revista Cubana De Química, 27(2), 163–181. Retrieved from https://cubanaquimica.uo.edu.cu/index.php/cq/article/view/260

Issue

Vol. 27 No. 2 (2015)

Section

Artículos

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