LC-MS Based Bioanalytical Techniques for Quantitative Estimation of Drugs Recent Advances and Regulatory Perspectives

Abstract

Conventional bioanalytical techniques like, high-performance liquid chromatography with ultraviolet or fluorescence detection, have long been used for drug quantification. However, these approaches had historically faced various limitations in sensitivity, selectivity, and reliability when applied to the quantitative estimation of drugs in complex biological matrices. These challenges included inadequate assessment of trace level analytes, interference from endogenous matrix constituents, in addition these methods also struggle to differentiate structurally related compounds, including metabolites and isomers, resulting in compromised accuracy. Collectively, these challenges have posed significant obstacles in pharmacokinetic, bioavailability, and bioequivalence studies, where precise and reproducible measurements are critical.

The introduction of liquid chromatography -mass spectroscopy (LC-MS) based bioanalytical techniques has substantially overcome these limitations. By integrating advanced chromatographic separation with high-sensitivity mass spectroscopy (LC-MS) enables the precise quantification of drugs and their metabolites even at minute levels. It offers high selectivity by identifying compounds based on their mass-to-charge ratio, which helps to reduce interference from other substances present in biological samples.

This study is carried out to provide a comprehensive understanding of LC-MS based bioanalytical techniques that are used in quantitative estimation of drugs in biological matrices. Due to increasing demand for highly sensitive, selective, and rapid analytical methods in pharmaceutical and clinical research, LC-MS has become an essential and indispensable asset.