The following parameters are considered during the analytical method validation of Assay:
1. System suitability
2. System precision
3. Sample precision
4. Solution stability and Mobile Phase stability
5. Assay Content
6. Accuracy
7. Linearity
8. Ruggedness
- With same analyst, same system, same column
- With same analyst, same system, but different column
- With same analyst, same column, but different system
- With same system, same column, but different analyst
9. Robustness
- Effect of temperature variation on the column
- Effect of flow variation
- Effect of variation in mobile phase organic composition
- Effect of pH variation in mobile phase
10. Different Batch analysis
Read also: Analytical Method Validation USP Guideline