An overview of the applications of LC-MS in characterizing pharmaceutical formulations, and in studying pharmacokinetic and pharmacodynamic parameters

In the last few decades, the hyphenated analytical techniques including liquid chromatography (LC) in combination with a mass spectrometer (MS) i.e., LC/MS, have made a major impact in pharmaceutical drug discovery and development. LC-MS hase been routinely used in pharmaceutical formulation development for drug substance and drug product characterization, molecular weight and fragmentation patterns determination, breakdown studies, and to identify impurities and degradation products. Recent advancements in LC-MS instrumentation, have allowed the technique to be implemented in several indications i.e., cancer, cardiovascular, respiratory, neurological, rare diseases etc. across preclinical (in vitro and in vivo) and clinical projects to evaluate pharmacokinetic and pharmacodynamic factors. LC-MS has overcome the sensitivity and dynamic range challenges to successfully identify and characterize drug molecules to help projects that use small molecules, biologics, and gene and cell therapy/editing platforms as drug modalities. This technique may provide several advantages over other analytical approaches including specificity, multiplexing, precision to quantify drug analyte or a biomarker in a variety of matrices like blood (plasma/serum), tissue, cerebrospinal fluid, urine, cells etc. In this review, we have highlighted LC-MS applications to study pharmaceutical formulations, pharmacokinetics and pharmacodynamics involving small molecule modality.