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    Influência da concentração, tempo de exposição e temperatura na estabilidade de soluções de cloridrato de vancomicina
    (Universidade Federal de São Paulo (UNIFESP), 2019-09-26) Onofre, Priscilla Sete De Carvalho [UNIFESP]; Peterlini, Maria Angelica Sorgini [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Introduction: Vancomycin hydrochloride is an antimicrobial widely used in the treatment of children with severe infections. Clinical practice has verified different methods of administration of drug solutions, with different diluents and concentrations, infusion period over one hour and exposure to environmental conditions, such as temperature and luminosity. These conditions raise the question about the possible impairment the stability of the medication, and scientific support is required to ensure proper administration practices, and safe nursing interventions. Objectives: To develop and validate analytical methodology to determine vancomycin hydrochloride content using High Performance Liquid Chromatography (HPLC); to analyze the stability of vancomycin hydrochloride solutions by verification of hydrogenic potential (pH) and content by HPLC based in concentration, infusion time, and exposure to high temperatures. Materials and Methods: The experimental study was developed in the Laboratory of Nursing Experiments of 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 hydrochloride at 5 and 10 mg/mL diluted in 0.9% sodium chloride and exposed to temperatures of 22 ± 2° C and 37 ± 2° C. The analyses were conducted immediately after preparation (T0), and after two (T2), and four (T4) h of exposure. The content analyzed was collected in three aliquots of each solution in all experimental situations, for a total of 108 analyses. For the pH, an aliquot of each solution was collected at all studied times, completing 36 measurements. The results were analyzed based on the mean (± standard deviation) and using ANOVA Variance and the multilevel linear regression model. Data normality was verified by Kolmogorov-Smirnov and Bonferroni correction tests (p ≤ 0.05). Results: The method was validated for the separation and quantification of vancomycin hydrochloride, and proved selective, linear, precise, accurate and robust. The pH did not vary during the 4 h exposure to the solution in all proposed situations, keeping its acid characteristic. In the diluted vancomycin hydrochloride solutions, to obtain 5 mg/mL and submitted to a temperature of 22 ℃. The men who did this were similar; however, there was a reduction at T4 (T0 = 101.93% ± 1.66; T2 = 101.45% ± 1.46; T4 = 100.31% ± 0.87; p < 0.001); the same situation was observed in the experiment at 37 ℃ (T0 = 106.12% ± 2.60; T2 = 106.02 ± 1.43; T4 = 104.83% ± 1.66; p < 0.001). The drug diluted to 10 mg/mL and exposed to a temperature of 22 °C resulted in an increase in T0 to T2 content, with a consecutive decrease in T4 (T0 = 92.96% ± 1.38; T2 = 94.39% ± 3.69; T4 = 91.86% ± 1.12; p = 0.006). For the 10 mg/mL vancomycin hydrochloride solution exposed at 37 ℃, the mean at T0 was lower when compared to other analysis times (T0 = 96.17% ± 2.25; T2 = 97.70% ± 1.50; T4 = 97.47% ± 0.68; p < 0.001). Despite the identified variations in drug content, the pharmacological stability of the solutions was observed due to changes of less than 10%. Conclusions: The chromatographic method for content analyses of vancomycin hydrochloride was considered valid. In the four-hour interval vancomycin hydrochloride diluted to 5 or 10 mg/mL showed statistically significant differences but remained stable according to the proportion of variability accepted to maintain pharmacological stability.