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HPLC qualification is a formal process that provides documented evidence that the instrument is fit for its intended use and kept in a state of maintenance and calibration consistent with its use.
Points to be Considered for HPLC Qualification
1. HPLC system suitability
2. Instrument calibration
3. Column performance
4. Mobile phase composition and preparation
5. Sample preparation and handling
6. Detector performance and sensitivity
7. Injection volume accuracy
8. Flow rate accuracy and precision
9. Gradient program verification
10. Temperature control and stability
11. Pressure control and stability
12. System leaks and integrity testing
13. Data acquisition system validation
14. Reproducibility of retention times
15. Linearity of detector response
16. Limit of detection (LOD) and limit of quantification (LOQ)
17. Robustness testing under different conditions (e.g., pH, temperature)
18. Carryover evaluation between samples
19. System suitability parameters (e.g., tailing factor, resolution)
20. Peak shape evaluation (e.g., asymmetry factor)
21. Repeatability of peak areas or heights
22. Accuracy of peak integration software algorithms
23. System maintenance procedures and schedules
24. Compliance with regulatory requirements (e.g., USP, EP, JP)
25. Method validation for specific analytes or compounds
26. Stability testing for mobile phase solutions
27. Impurity analysis and identification
28. Forced degradation studies
29 .System performance over extended periods of time
30 .Training and qualification of personnel operating the HPLC system
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