DEVELOPMENT AND VALIDATION OF HOLLOW-FIBER LIQUID PHASE MICROEXTRACTION FOR TOPIRAMATE ANALYSIS IN BIOLOGICAL FLUID

Topiramate (TPM) is an antiepileptic drug and it is currently used as an adjunctive agent for the control of partial and generalised seizures in both adults and children (1). Due to its high interindividual variability, drug interactions and the adverse effects presented during the TPM administration, therapeutic drug monitoring is very important to dose adjustment and to avoid toxicity effects. Analyzes in biological samples has already been described using several sample preparation techniques such as liquid-liquid extraction and solid phase extraction. These extraction require intensive work and sometimes the use of large amounts of organic solvents (2). Thus, the goal of this study is to develop and validate the hollow fiber liquid-phase microextraction technique (HF-LPME) to analyze TPM in plasma samples of epileptic patients. For extraction optimization, fractional factorial designs and central composite designs were used. The validation was successfully performed according to ANVISA and EMA guidelines.