Separation of cold medicine ingredients using a precise MEKC method at elevated pH.

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Cold medicine formulations contain multiple active pharmaceutical ingredients (APIs) with similar physicochemical properties.
• Complex matrices with high alcohol, sucrose, and excipient content pose significant challenges for accurate API separation and quantification.

Purpose of the Study:

• To develop and optimize a Micellar Electrokinetic Chromatography (MEKC) method for separating key APIs in a cold medicine.
• To address challenges related to similar compound properties and complex formulation matrices.

Main Methods:

• Micellar Electrokinetic Chromatography (MEKC) was employed for separation.
• Optimization involved determining optimal pH and sodium dodecyl sulfate (SDS) concentration.
• Benzocaine was utilized as an internal standard for quantitative analysis.

Main Results:

• The developed MEKC method successfully separated acetaminophen, ephedrine sulfate, doxylamine succinate, and dextromethorphan hydrobromide.
• Optimization minimized matrix-capillary wall interactions and ensured analytical precision.
• The method achieved high quantitative performance with relative standard deviation (RSD%) values for peak areas between 1.0% and 2.0%.

Conclusions:

• The optimized MEKC method provides a robust and precise approach for analyzing multi-component cold medicine formulations.
• The developed strategy is applicable to similar complex pharmaceutical separations.
• This analytical method enhances the quality control of cold medicines.