The following parameters are considered during the analytical method validation of related substances or residual solvents:
1. Demonstration of precision
- System precision / System suitability
- Sample precision
2. Solution stability
3. Limit Of Detection (LOD)
4. Limit Of Quantification (LOQ)
- Precision at LOQ level
- Accuracy at LOQ level
- Linearity at LOQ level
5. Accuracy
6. Linearity
7. Ruggedness
- On the same column at spiked level
- Variability from analyst to analyst
- Variability from system to system
- Variability from column to column
8. Robustness
- Variability of column initial oven temperature
- Variability of carrier gas flow rate
9. Different Batch analysis
Read also: Analytical Method Validation of Assay