Chromatography and Analytical Techniques

Bioanalytical Chromatography

Bioanalytical chromatography plays a crucial role in the quantification and characterization of biomolecules such as proteins, peptides, nucleic acids, and metabolites in biological matrices. These techniques are pivotal in pharmacokinetics, pharmacodynamics, bioequivalence studies, and therapeutic drug monitoring. Liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) is the gold standard in bioanalysis due to its sensitivity, specificity, and throughput. Advances in sample preparation methods like protein precipitation, solid-phase extraction (SPE), and microextraction have streamlined workflows and reduced matrix effects. Furthermore, developments in nano-LC, microfluidic chips, and automation are enabling more accurate and reproducible analysis of low-abundance biomarkers. Regulatory agencies emphasize rigorous method validation, including parameters like selectivity, precision, and stability, making method robustness crucial. In addition to small molecule drugs, bioanalytical chromatography is now central in biologics and biosimilar analysis, including monoclonal antibodies and gene therapies. As personalized medicine and biomarker-driven therapies expand, bioanalytical chromatography continues to provide the analytical backbone for advancing healthcare outcomes and precision diagnostics.