Why not using capillary electrophoresis in drug analysis?

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Capillary Electrophoresis (CE) is a powerful separation technique for biomolecules.
• Despite its advantages over High-Performance Liquid Chromatography (HPLC) for drug impurity and enantiomeric purity analysis, CE is underutilized in pharmaceutical settings.
• Reservations from regulatory bodies and pharmacopoeia commissions contribute to CE's limited application.

Purpose of the Study:

• To highlight the advantages of CE over HPLC in specific drug analyses.
• To demonstrate CE's superiority in analyzing antibiotics, amino acids, peptides, and determining enantiomeric purity.
• To advocate for increased adoption of CE in pharmaceutical quality control.

Main Methods:

• Review of existing literature and experimental data.
• Comparative analysis of CE and HPLC for drug quality control applications.
• Discussion of method adaptation for pharmacopoeial compliance.

Main Results:

• CE demonstrates superior performance compared to HPLC in analyzing specific drug classes, including antibiotics, amino acids, and peptides.
• CE is highly effective for determining the enantiomeric purity of drug substances.
• Adjusting electrophoretic conditions is crucial for meeting system suitability criteria without altering fundamental methods.

Conclusions:

• CE presents a valuable alternative to HPLC for critical drug quality control parameters.
• Standardization and optimization of CE methods are necessary for broader acceptance by pharmacopoeias.
• Increased application of CE in drug quality control is recommended for enhanced analytical outcomes.