Estudo de estabilidade do padrão azitromicina utilizado na rotina do controle de qualidade

Abstract

The pharmaceutical industry is responsible for producing safe and effective medicines for health, contributing to the quality of life of the population. In order for the product to reach the final consumer, quality control is an essential step in the drug manufacturing process. In this sense, the use of quality standards and that guarantee reliable results is of paramount importance. Linked to this and aiming at cost reduction, analytically know when and when storage conditions are ideal to optimize the process. In this context, the objective of this work was the stability study of the chemical substance azithromycin, obtained from the Pharmaceutical Industry Prati-Donaduzzi. The standard was stored in the refrigerator (2 - 8 ° C) and oven (30 ° C) condition and over time the recovery by high performance liquid chromatography was evaluated against two analytical methods, corresponding to the two forms of releases of the finished product company. Two studies were evaluated for the compressed azithromycin method, one with the shortest time 20 hours and the other with up to 117 hours. When evaluating the recovery, it was reported that storage in the greenhouse condition was the most efficient, since the recovery of the standard was within the specification from 98.5% to 101.5% in up to 117 hours. Regarding the active evaluated by the analytical methodology powder for oral suspension, the refrigerator condition up to 113 hours was more effective in relation to the greenhouse condition.