Analytical Test Method Validation and Verification
Pre-Validation Requirements:
- Gather your tools and materials, ensuring they meet the highest standards of quality and traceability.
- Verify the analytical system’s design, maintenance, and qualification to guarantee consistent performance.
Specificity:
- Achieve unequivocal identification of your analyte, even in the presence of potential impurities or matrix components.
- Employ identification and purity tests to ensure accurate determination of impurities and content.
Linearity and Range:
- Establish a concentration range where your method delivers precise, accurate, and linear results.
- Verify that your method can handle samples within the expected working range.
Accuracy and Precision:
- Explore the accuracy and recovery studies to ensure your results are consistently within acceptable limits.
- Assess repeatability, within-day, and between-day precision to demonstrate the reliability of your method.
Robustness:
- Test the resilience of your method against small variations in parameters like flow rate, mobile phase composition, and injection volume.
- Ensure your method remains unaffected by these deliberate changes, guaranteeing reliable performance.
Limit of Detection & Quantitation:
- Determine the lowest concentration at which your analyte can be detected and quantified with confidence.
- Calculate LOD and LOQ using standard deviation and slope values.
System Suitability:
- Perform system suitability tests to verify reproducibility, efficiency, tailing, and resolution before analyzing unknown samples.
- Ensure your system meets predefined criteria for precision, resolution, tailing factor, capacity factor, and theoretical plates.
Observations and Deviations:
- Keep a watchful eye for any deviations from protocol requirements and document them promptly.
- Investigate the causes, assess the impact on operations, and take corrective actions to maintain data integrity.
Analytical test method validation is a cornerstone of scientific accuracy and precision.
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