Inter-instrumental method transfer of chiral capillary electrophoretic methods using robustness test information

Area of Science:

• Analytical Chemistry
• Separation Science

Background:

• Capillary electrophoresis (CE) is a flexible, cost-effective technique for chiral molecule separation.
• Method transfer in CE faces challenges due to instrumental variability and response variability, impacting precision and efficiency.
• Successful method transfer is essential as method development and routine use often occur in different settings.

Purpose of the Study:

• To develop standardized rules for facilitating capillary electrophoresis method transfers between diverse laboratories and instruments.
• To address the known issues of precision and method transferability in CE.
• To ensure consistent and reliable chiral separations across different CE platforms.

Main Methods:

• Optimization of chiral CE method precision for selected beta-blockers.
• Conducting a robustness test to identify critical instrumental and experimental parameters.
• Performing inter-instrumental transfers with and without adapted settings based on robustness data.

Main Results:

• Identified key parameters influencing CE method responses through robustness testing.
• Developed and validated adapted instrumental and method settings to enhance transferability.
• Demonstrated significant improvement in transfer success rates using the derived rules.

Conclusions:

• Established practical rules to facilitate robust and reliable CE method transfers.
• The developed guidelines improve the consistency of chiral separations across different instruments.
• This work enhances the routine application of CE in analytical laboratories by overcoming transfer limitations.