Simultaneous multiresponse optimization applied to epinastine determination in human serum by using capillary...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Epinastine hydrochloride analysis in biological matrices is crucial for therapeutic drug monitoring.
• Existing methods may lack the speed and simplicity required for routine clinical use.

Purpose of the Study:

• To develop and optimize a rapid, simple, and accurate capillary zone electrophoresis method (CZE) for epinastine hydrochloride determination in human serum.
• To establish optimal separation conditions using experimental design and desirability function.

Main Methods:

• Capillary Zone Electrophoresis (CZE) with UV detection.
• Experimental design and multiple response simultaneous optimization (desirability function) to optimize buffer concentration/pH, injection, and separation voltages.
• Liquid-liquid extraction for serum sample clean-up.

Main Results:

• Optimized CZE method achieved high resolution and short analysis time.
• Linearity was confirmed in the 2.0-12 ng mL(-1) range with excellent precision (CV < 2%) and accuracy.
• Liquid-liquid extraction yielded a high recovery rate (93.00%) for epinastine hydrochloride.

Conclusions:

• The developed CZE method is rapid, simple, precise, and accurate for epinastine hydrochloride quantification in human serum.
• This method offers a viable alternative to HPLC for routine pharmaceutical analysis and therapeutic drug monitoring.