Bioanalytical Method Development –Determination of Drugs in Biological Fluids

One of the major challenges facing the pharmaceutical industry today is finding new ways to increase productivity, decrease costs whilst still ultimately developing new therapies that enhance human health. One of the major challenges facing the pharmaceutical industry today is finding new ways to increase productivity,decrease costs whilst still ultimately developing new therapies that enhance human health.To help address these challenges the utilisation of analytical technologies and high-throughput automated platforms has been employed; in order to perform more experiments in a shorter time frame with increased data quality. During the last decade, quantification of low molecular weight molecules using liquid chromatography–tandem mass spectrometry in biological fluids has become a common procedure in many preclinical and clinical laboratories. This overview highlights a number of issues involving “small molecule drugs”, bioanalytical iquid chromatography–tandem mass spectrometry, which are frequently encountered during assay development. Since plasma is one of the most widely adopted biological fluid in drug discovery and development, the focus of this discussion will be limited to plasma analysis. Bioanalytical method development largely depends on the experience and the preference of the developer.Mathematical models could help in selecting the proper conditions to develop a selective and robust method, using liquid chromatography, liquid–liquid extraction, solidphase extraction and protein precipitationSpecial attention has been paid to matrix effects, the most important issues in bioanalysis and possible solutions to handle these issues are discussed.By proper use of the proposed models a more structured method development is accomplished, resulting in a description of the method that could be used for future use to control the complete Bioanalytical method.