Method Optimization in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting method optimization during the analytical method development process, improving method performance and efficiency.

2) Scope

This SOP applies to all personnel involved in method optimization for analytical method development projects within the analytical development department.

3) Responsibilities

The purpose of this SOP is to define the roles and responsibilities of all personnel involved in method optimization.

4) Procedure

1. Review of Initial Method Performance:
   1. Assess initial method performance based on accuracy, precision, and sensitivity.
   2. Identify areas for improvement or optimization.
2. Parameter Variation:
   1. Vary method parameters such as mobile phase composition, pH, temperature, and gradient conditions.
   2. Systematically evaluate each parameter variation to optimize method performance.
3. Data Analysis and Evaluation:
   1. Analyze optimization data to determine the impact of parameter variations on method performance.
   2. Compare optimized method performance with initial method performance.
4. Validation of Optimized Method:
   1. Validate optimized method parameters to ensure robustness and reliability.
   2. Document optimized method parameters and validation results.
5. Review and Approval:
   1. Review the optimization report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the optimization report.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to method optimization in analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Method Optimization Report
• Parameter Variation Records
• Data Analysis and Results Documentation
• Optimized Method Validation Records
• Review and Approval Records

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q2(R1): Validation of Analytical Procedures
• USP General Chapter Validation of Compendial Methods

8) SOP Version

Version 1.0