METHOD VALIDATION FOR QUANTIFICATION OF CARBAMAZEPINE AND VALPROIC ACID IN CAPILLARY BLOOD COLLECTED BY ONEDRAW

Abstract

Introduction: Individuals undergoing treatment for epilepsy may have difficulty adhering to treatment. Among the reasons, forgetfulness and adverse effects caused by medication can be highlighted. With this scenario, it is understood that there is a need to carry out therapeutic monitoring of patients undergoing treatment for epilepsy. The OneDraw device, which allows you to obtain a capillary blood sample from its fixation in the upper part of the arm, eliminates some of the obstacles encountered in collecting capillary blood by the finger, such as pain, discomfort and waiting time. Material and methods: The validation of a method in High Performance Liquid Chromatography coupled to Mass Spectrometry (HPLC-MS/MS) was carried out, following the validation parameters of the Food and Drug Administration for the quantification of carbamazepine (CBZ) and Valproic acid (AV) in dry blood spots. Result: The method demonstrated high sensitivity for the detection of CBZ and AV in capillary blood samples. The detection limit of the method was 1.0 mg L-1 for CBZ and 10 mg L-1 for AV. Intra-assay precision was 3.29 to 6.75% for CBZ and 4.67 to 6.54% for AV. Discussion: Although other techniques exist, the use of HPLC-MS/MS is the main technique used for the analysis of anticonvulsants in DBS due to its high sensitivity and selectivity. Conclusion: Therefore, a simple and sensitive method is being validated for CBZ and AV quantification in capillary blood samples collected with the OneDraw device.