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Development and validation of an HPLC method for the determination of fluorouracil in polymeric nanoparticles

By Ana Cristina de Mattos, Najeh Maissar Khalil and Rubiana Mara Mainardes

Abstract

The objective of this work was to develop and validate a rapid high performance liquid chromatography (HPLC) method for the quantitative analysis of fluorouracil (5-FU) in polymeric nanoparticles. Chromatographic analyses were performed on an RP C18 column with a mobile phase consisting of acetonitrile and water (10:90, v/v) at a flow rate of 1 mL/min. The 5-FU was detected and quantitated using a photodiode array detector at a wavelength of 265 nm. The method was shown to be specific and linear in the range of 0.1-10 µg/mL (r = 0.9997). The precision (intra- and inter-day) was demonstrated because the maximum relative standard deviation was 3.51%. The method is robust relative to changes in flow rate, column and temperature. The limits of detection and quantitation were 10.86 and 32.78 ng/mL, respectively. The method fulfilled the requirements for reliability and feasibility for application to the quantitative analysis of 5-FU in polymeric nanoparticles.<br>O objetivo deste trabalho foi desenvolver e validar um método rápido de cromatografia líquida de alta eficiência (CLAE) para análise quantitativa de fluorouracila (5-FU) em nanopartículas poliméricas. Corridas cromatográficas foram realizadas sob uma coluna RP C18 com uma fase móvel consistindo de acetonitrila e água (10:90, v/v) a um fluxo de 1 mL/min. O 5-FU foi detectado e quantificado através de um detector de fotodiodos em um comprimento de onda de 265 nm. O método demonstrou ser específico e linear na faixa de 0,1-10 µg/mL (r =0.9997). As precisões (intra e inter dia) revelaram um desvio padrão relativo máximo de 3,51%. O método é robusto considerando mudanças realizadas no fluxo da fase móvel, temperatura e marca da coluna. Os limites de detecção e quantificação foram de 10,86 e 32,78 ng/mL, respectivamente. O método cumpriu os requisitos para ser considerado confiável e viável para aplicação na análise quantitativa de 5-FU em nanopartículas poliméricas

Topics: Fluorouracila, Nanopartículas, Cromatografia líquida de alta eficiências, Cromatografia líquida de alta eficiências, Fluorouracil, Nanoparticles, High performance liquid chromatography, High performance liquid chromatography, Pharmacy and materia medica, RS1-441, Medicine, R, DOAJ:Pharmacy and materia medica, DOAJ:Medicine (General), DOAJ:Health Sciences
Publisher: Universidade de São Paulo
Year: 2013
OAI identifier: oai:doaj.org/article:8129bf20054143b28c2f6d09ce7078f1
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