From Burettes to Biosensors: A Review on the Advancements in Pharmaceutical Quantitative Analysis

Abstract

Quantitative analysis is the cornerstone of pharmaceutical quality assurance, ensuring the safety, efficacy, and consistency of therapeutic agents. Over the past several decades, the methodologies driving pharmaceutical quantification have undergone a profound paradigm shift, spurred by the need for greater sensitivity, selectivity, and high-throughput capabilities.

This review traces the evolutionary trajectory of pharmaceutical quantitative analysis, chronicling its transition from classical wet chemical methods to state-of-the-art analytical technologies.

The review commences with an examination of foundational classical techniques, including titrimetry and gravimetry, noting that despite their simplicity and cost-effectiveness, they present distinct limitations regarding automation and trace detection. The narrative then transitions to the advent of instrumental analysis exploring the revolutionary impact of spectrophotometric methods and chromatographic separations. Special emphasis is placed on the modern era of hyphenated techniques—such as LC-MS and GC-MS—which have redefined complex mixture analysis and impurity profiling.

By bridging the gap between historical practices and contemporary innovations, this review provides a comprehensive roadmap of pharmaceutical analysis, offering insights into future trends that will continue to shape regulatory compliance and drug development.