Capillary Electrophoresis Applications in Pharmaceutical Analysis

Capillary electrophoresis (CE) has emerged as a versatile separation technique in pharmaceutical analysis, exploiting electric fields to resolve compounds by charge and size within narrow-bore capillaries. Its minimal sample and solvent requirements, high separation efficiency and rapid analysis times make it an attractive alternative to traditional chromatographic methods. In drug development and quality control, CE addresses critical needs such as enantiomeric purity assessment, impurity profiling, peptide and protein characterisation, and monitoring of biopharmaceutical formulations. Recent advances in capillary surface modification, buffer chemistry and instrumental hyphenation have further expanded its applicability, enabling robust analysis in complex matrices, integration into continuous manufacturing workflows and deeper insight into molecular heterogeneity. With growing emphasis on process analytical technology and regulatory expectations for high-resolution separations, CE stands at the forefront of modern pharmaceutical laboratories worldwide.

Research from Nature Portfolio

Innovations in stationary phase design have yielded polymeric monoliths with tunable pore structures that enhance resolution across a broad molecular weight range, facilitating simultaneous analysis of small-molecule APIs and therapeutic peptides in a single run. A second development features a microfluidic CE-MS platform optimised for early-stage drug metabolite profiling, integrating sheathless electrospray interfaces to achieve sub-nanomolar sensitivity while reducing carry-over. Thirdly, novel zwitterionic buffer systems have demonstrated improved electroosmotic flow stability and chiral selectivity, enabling reproducible enantiomeric separations of basic and neutral drug candidates without extensive method development. Together, these studies underscore the technique’s adaptability to diverse pharmaceutical challenges and its potential to streamline both discovery and quality assurance phases.

Capillary Electrophoresis Applications in Pharmaceutical Analysis publication trend

The graph below shows the total number of articles in capillary electrophoresis applications in pharmaceutical analysis across all publications each year (not limited to Nature Index journals).

Technical terms

Capillary electrophoresis (CE): A separation technique using an electric field to move analytes through a narrow capillary based on charge-to-size ratio.

Electroosmotic flow (EOF): Bulk liquid movement in CE capillaries induced by an applied electric field acting on the charged capillary wall.

Monolithic polymeric capillaries: Continuous porous polymer structures within capillaries that serve as a separation matrix with adjustable pore sizes.

Sheathless electrospray interface: A coupling strategy for CE-MS that eliminates sheath liquid, improving sensitivity and reducing dilution.

Zwitterionic buffers: Amphoteric buffer systems containing both positive and negative charges to stabilise EOF and improve selectivity.

Enantiomeric excess (ee): A measure of purity indicating the proportion of one enantiomer over its mirror image in a chiral mixture.

Process analytical technology (PAT): Framework of analytical tools used in pharmaceutical manufacturing to monitor and control critical quality attributes in real time.