Desinfetante de uso geral à base de clorexidina: formulação, validação da metodologia analítica de doseamento, estabilidade preliminar e avaliação da eficácia microbiológica.

Abstract

In this work was obtain a general formulation purpose based chlorhexidine disinfectant from the manipulation of 15 pilots. The choice of the active agent formulation, chlorhexidine digluconate, was made based on their chemical properties and toxicological and its scope of action. The choice of the formulation other ingredients (benzalkonium chloride, cetyl trimethyl ammonium chloride, ethoxylated nonyl phenol, coloring, essence and distilled water) occurred through bibliographical studies, but also by the technical development of the formulation. After the formulation development, was held to validate the active agent analytical method for quantification by spectophotometry UV/VIS, where the follow parameters were evaluated: selectivity, linearity, range, accuracy, precision and robustness. In order to determinate the disinfectant useful life of, were performed accelerated stability testing and shelf. For this reason, was performed the formulation physico-chemical evaluate by analysis of the appearance, pH and viscosity, on storage conditions forced followed the analysis of the content of active in the formulations after 40 days stored at 50 ° C in a stove and 25 ° C shelf. Additionally, we tested the formulations efficacy through of the analysis by microbiological control, realized by a classical method of successive dilution and qualitative (Minimum Inhibitory Concentration) with the aim of verify the disinfectant formulations antimicrobial action for Escherichia coli and Staphylococcus aureus. Pending the formulation development was verified the incompatibility between the hydrosoluble dye and the cetyl trimethyl ammonium chloride, and this critical point was solved removing this last component of the formulation. Thefore, we obtained the pilot formulation 14 as approved for of the tests continuity. By scanning was found the ideal wavelength for quantifying the content of active (230 nm) in aqueous solution at a concentration of 7.5 mg/mL. Moreover, the analytical methodology validation was satisfactory, being possible to quantify the amount of the active disinfectant present in the formulation to 3.0 mg/mL, using as correction factor 0.4. The stability results compared to the conditions of the study conducted here found no significant changes compared formulations at time zero and after accelerated stability study and shelf. Relative microbiological control, formulations analyzed showed satisfactory antimicrobial efficacy to inhibit microorganisms under test in the lowest concentration used in the study. Given these results, the developed product is suitable to be used as general purpose disinfectant.