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.

Read also: Robustness in Analytical Method Validation