LC/MS methods for small molecule biomarkers

Abstract

Small molecule biomarkers provide insight into metabolic pathways related to therapeutic treatment and can help explain the mechanism of action during drug development. LC-MS-MS method approaches parallel those for drug pharmacokinetic analyses; the optimization of detection, chromatographic system, and extraction are similarly important to achieving good quantitation. Endogenous presence of small molecule biomarkers presents a unique challenge for developing and validating an LC-MS-MS assay and several strategies are available to address it. Additional challenges for small molecule biomarker assays are sensitivity, ion suppression/matrix effects, and assay selectivity. Innovative solutions for overcoming these hurdles are discussed in this chapter.