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Procedure and Key Optimization Strategies for an Automated Capillary Electrophoretic-based Immunoassay Method

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Multiple response optimization applied to the development of a capillary electrophoretic method for pharmaceutical

Luciana Vera Candioti¹, Juan C Robles, Víctor E Mantovani

¹Laboratorio de Control de Calidad de Medicamentos, Cátedra de Química Analítica I, Facultad de Bioquímica y Ciencias Biológicas, Universidad Nacional del Litoral, Ciudad Universitaria, Santa Fe, Argentina.

|October 31, 2008

Summary

A new capillary electrophoresis method efficiently determines four active pharmaceutical ingredients simultaneously. This method offers high precision and accuracy, comparable to HPLC, for quality control.

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Area of Science:

Analytical Chemistry
Pharmaceutical Analysis

Background:

Accurate simultaneous determination of multiple active pharmaceutical ingredients (APIs) is crucial for drug quality control.
Existing methods may have limitations in terms of efficiency or scope for complex pharmaceutical preparations.

Purpose of the Study:

To develop and optimize a capillary electrophoresis (CE) method for the simultaneous determination of four APIs: vitamins B6, B12, dexamethasone, and lidocaine hydrochloride.
To achieve high resolution, short analysis time, and improved separation quality using simultaneous optimization.

Main Methods:

Capillary Zone Electrophoresis (CZE) using a silica capillary and UV detection at 240 nm.
Multiple response simultaneous optimization utilizing the desirability function.
Optimization of five responses: three resolutions, analysis time, and capillary current.

Main Results:

Optimal conditions determined: 57.0 mmol/L sodium phosphate buffer (pH 7.0) and 17.2 kV voltage.
Achieved high precision (CV < 2%) and accuracy (98.5-102.6% recovery) for the four compounds.
The developed CE method demonstrated comparable performance to High-Performance Liquid Chromatography (HPLC).

Conclusions:

The optimized CZE method provides a robust and efficient approach for simultaneous analysis of the target APIs.
This method is suitable for routine quality control of pharmaceutical preparations.
Simultaneous optimization using the desirability function effectively balances multiple analytical requirements.