Validation and Implementation of a method for vancomycin therapeutic monitoring in a university hospital

Abstract

Vancomycin is a hospital antibiotic used in Gram+ bacteria infection. The recommended plasma concentration is 15 - 20 µg/mL, values above can cause nephrotoxicity and ototoxicity. This, added to the intra-individual pharmacokinetic variations, makes it an excellent candidate for therapeutic monitoring, which, through the measurement and interpretation of plasma levels, ensures effective and safe individualized doses. So, this study is a method validation for the determination of vancokinemia by high performance liquid chromatography with a UV detector and the application in a Santa Catarina - Brazil hospital. The method obtained linearity between 5 – 100 µg/mL with a Lower Limit of Quantitation of 5 µg/mL and Limit of Detection of 1.45 µg/mL, presented adequate repeatability, intermediate precision, intraday/interday accuracy according to legislation and no matrix effect. Samples were stable for 24 hours at room temperature, 48 hours post-processing, up to 8 months stored and up to 2 freeze/thaw cycles. The method was applied to four patients, with 12 determinations performed, 66% indicated the need for a change in dose. In conclusion, the method was successfully validated and applied in the hospital, with challenges to be resolved in the continued use of the method.