P0513 / #1763: INFLUENCE OF CONCENTRATION, EXPOSURE TIME, AND TEMPERATURE ON THE STABILITY OF VANCOMYCIN HYDROCHLORIDE SOLUTIONS

Abstract

Aims & Objectives: To analyze the stability of vancomycin solutions by verification of pH and content using High Performance Liquid Chromatography(HPLC) based in concentration, infusion time and temperatures. Methods: The study was developed in the Federal University of São Paulo. To validate the analytical methodology the selectivity parameters, linearity, work range, matrix effect, robustness, precision, and accuracy were determined. The sample was composed of 12 solutions. Chemical stability was analyzed using the pH and content of vancomycin at 5 and 10mg/mL diluted in 0.9% sodium chloride and exposed to temperatures of 22±2°C and 37±2°C. The analyses were conducted after preparation(T0), and after two(T2), and four(T4) hours of exposure;108 HPLC analyzes and 36 for pH measurement were performed.The results were analyzed using ANOVA Variance and the multilevel linear regression model. Results: The method was validated for separation and quantification of vancomycin. The pH did not vary during the 4hours exposure. In the diluted vancomycin solutions, to 5mg/mL a temperature of 22°C, the averages in T0 and T2 were similar, but there was a reduction at T4(p<0.001); the same situation was observed at 37°C. The drug diluted to 10 mg/mL and exposed at 22°C resulted an increase in T0 to T2 content, with a consecutive decrease in T4(p=0.006). For the 10mg/mL vancomycin solution exposed at 37°C, the mean at T0 was lower when compared to other analysis times (p<0.001). Conclusions: In the four-hour interval vancomycin diluted 5 or 10mg/mL showed statistically significant differences but remained stable according to the proportion of variability accepted to maintain pharmacological stability (10%).