Validación del Método Analítico de Valoración de Sulfametoxazol en suspensión oral producido por Farbiovet S.A. mediante Hplc.

Abstract

The analytical method was validated to quantify Sulfamethoxazole present in an oral suspension produced by the veterinary pharmaceutical industry FARBIOVET S.A. through High Performance Liquid Chromatography (HPLC) based on the requirements established by the World Health Organization in order to control Good Manufacturing Practices. It was prepared samples and the standard according to established procedures, it was used a Sulfamethoxazole Sigma Aldrich standard with 99.5% purity and it was analyzed by HPLC with a UV/VIS detector at a wavelength of 254 nm and one Nucleosil C18 column. For the development of the validation process, it was analyzed and statistically evaluated various parameters detailed in an Annual Validation Plan internally set by the company, in which the linearity, selectivity, precision, accuracy, limits of detection and quantification, robustness and uncertainty are suited. All procedures are documented in a Validation Protocol to clearly identify all steps in the process. After the validation process it was observed that the Sulfametoxazole chromatogram does not presents peaks that interfere the qualification active, it was shown that the analyte concentration is linear against the response team, the method is accurate obtaining a coefficient or variation less that 2%, is correct because the recovery rate is 99% to 101%, though robustness was determined that the injection volume varies significantly in the results obtained and the uncertainty is 0.18%, showing that the method meets the criteria set by the statistical analysis of each of the parameters. It is recommended the use or this validated method by FARBIOVET S.A. to ensure the quality of the product.