Automated UHPLC separation of 10 pharmaceutical compounds using software-modeling.

Area of Science:

• Analytical Chemistry
• Pharmaceutical Science
• Regulatory Affairs

Background:

• Human errors are a significant challenge in regulatory affairs and analytical method development.
• Compliance with FDA's Data Integrity and Analytical Quality by Design (AQbD) necessitates the elimination of such errors.

Purpose of the Study:

• To develop smooth, fast, and robust analytical methods free from human failures.
• To evaluate the effectiveness of state-of-the-art automation in analytical method development.

Main Methods:

• Utilized commercial software (DryLab) for automated method development.
• Employed a model mixture of 10 drugs for testing.
• Applied Analytical Quality by Design (AQbD) principles to select the optimal working point.
• Performed confirmatory experimental runs based on robustness calculations.

Main Results:

• Simulated results from the software demonstrated excellent agreement with experimental outcomes.
• The automated approach proved effective in developing robust analytical methods.
• Successfully identified and mitigated potential human errors in the method development process.

Conclusions:

• Software-assisted, automated analytical method development is a viable strategy to enhance data integrity and compliance.
• This approach effectively minimizes human error, leading to faster and more robust methods.
• The study validates the use of automation in meeting stringent regulatory requirements like AQbD.