Bioanalytical Method Development Of Lipids, Peptides, And Small Molecules By LC-MS/MS

By Uday Velagapudi, Ph.D.

Drug substances and novel excipients are frequently quantified in a variety of biological matrices — such as blood, plasma, serum, and tissues — to monitor their absorption, distribution, metabolism, and excretion. Accurate measurement in these complex sample types is essential for evaluating how compounds are resorbed and eliminated from the body.

This paper focuses on the critical role of sample preparation optimization and the application of liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in bioanalytical method development. Emphasis is placed on refining these techniques to ensure high sensitivity, specificity, and reproducibility. The overarching goal is to establish a robust analytical framework capable of reliably assessing the absorption capacity, bioavailability, and biodistribution of drug candidates and innovative excipients prior to method validation, ultimately supporting informed decision-making in drug development.