LC method for the therapeutic drug monitoring of lamotrigine: evaluation of the assay performance and validation of its application in the routine area.

An accurate and precise high-performance liquid chromatographic method using diode array detection for the determination of lamotrigine in human plasma has been developed and validated for use in pharmacokinetic studies. A validation strategy based on the accuracy profiles was used to select the most appropriate regression model and to determine the limits of quantitation as well as the concentration range. On the other hand, the present paper also shows this validation approach as a suitable tool to guaranty the quality of the results obtained by the use of the analytical validated methodology for plasma lamotrigine determination in a routine setting and to ensure the risk of obtaining the future measurements outside the previously fixed acceptance limits.