Ciclopirox olamina: desenvolvimento e validação de métodos de análise

Abstract

The frequency of fungal infections has risen drastically during the last decades due to the increasing human lifespan, even in cases of grave sickness, because of the advance in the capacity of science and medical technology. This survival rate has brought about a manifestation of fungal infections at new proportions, which has raised the interest in studying anti-fungal drugs. Ciclopirox olamina is a synthetic anti-fungal agent with a wide spectrum of action, with inherent anti-inflammatory and anti-bacterial activities. This drug does not have an official monograph in the Brazilian Pharmacopeia. In this study, methods for the quantification of ciclopirox olamina as a raw material and in a topical solution were developed and validated, using High Performance Liquid Chromatography (HPLC) with detection in the ultraviolet region, and a microbiological assay by agar diffusion. In the determination by HPLC-UV, the analyses were conducted in a reverse phase column C18, at a temperature of 30º. In the microbiological assay by agar diffusion, 3x3 planning was used, employing Candida albicans ATCC 10231 as a microorganism test. Both methods presented adequate linearity, precision and accuracy.