APPLICATION OF ANALYTICAL QUALITY BY DESIGN APPROACH TO BIOANALYTICAL METHODS - SIMULTANEOUSLY QUANTIFICATION OF ANTIEPILEPTIC DRUGS IN HUMAN SALIVA

Arlinda Haxhiu Zajmi, Gjylai Alija, Drita Havziu, Jasmina Tonic Ribarska

Abstract

Bioanalytical methods play a significant role in therapeutic drug monitoring (TDM) with the main objective, the implementation of a rational therapy. The obtained results from bioanalytical method should be consistent, reliable and with high quality, in order to apply for therapeutic monitoring in routine clinical practice. Analytical Quality by Design - AQbD is required as an essential tool during the process of development, optimisation, validation and routine application of bioanalytical method. The aim of this paper is to introduce the concept of analytical quality by design (AQbD), in the development of robustness bioanalytical method for simultaneous determination of antiepileptic drugs (lamotrigine, levetiracetam, valproic acid, carbamazepine and its active metabolite carbamazepine-10,11-epoxide) in human saliva. The proposed and validated methods have been successfully applied for determination of those antiepileptic drugs in saliva collected from epileptic patients that are under the therapy. The results and conclusions confirmed that during the development and optimisation of bioanalytical method, the application of AQbD provide better reliability and quality of obtained bioanalytical data.

Pages: 11 - 24