Developing Chromatographic Methods for Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for developing chromatographic methods during the analytical method development process, ensuring accurate separation and quantification of analytes in pharmaceutical formulations.

2) Scope

This SOP applies to all personnel involved in developing chromatographic methods 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 developing chromatographic methods.

4) Procedure

1. Method Development Objectives:
   1. Define objectives for developing chromatographic methods based on regulatory requirements and product specifications.
   2. Identify target analytes and establish method acceptance criteria.
2. Selection of Chromatographic Technique:
   1. Evaluate and select appropriate chromatographic technique (e.g., HPLC, GC) based on analyte properties and detection requirements.
   2. Consider method sensitivity, selectivity, and robustness.
3. Optimization of Method Parameters:
   1. Optimize chromatographic method parameters such as mobile phase composition, column type, flow rate, and detection wavelength.
   2. Perform system suitability tests to ensure method performance meets predefined criteria.
4. Validation of Chromatographic Methods:
   1. Validate chromatographic methods according to regulatory guidelines and predefined acceptance criteria.
   2. Document validation results and conclusions regarding method suitability for analyte quantification.
5. Documentation and Reporting:
   1. Document all chromatographic method development activities, including method objectives, technique selection, optimization, and validation.
   2. Prepare a chromatographic method development report summarizing method development activities and outcomes.
6. Review and Approval:
   1. Review the chromatographic method development report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the chromatographic method development report.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Chromatographic Method Development Report
• Validation Results Documentation
• System Suitability Test Records
• Review and Approval Records
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

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

8) SOP Version

Version 1.0