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Deferred standards, an on-line qualification, validation and system stability probe for chromatographic assay
I Clarot1, M F Dreyfuss, R Domelier
1Laboratoire de Chimie Analytique, Faculté de Pharmacie, Nancy, France.
Journal of Chromatography. A
|July 24, 2002
Summary
Automated HPLC systems can now perform on-line qualification, validation, and stability monitoring using deferred standards. This method enhances routine analysis by tracking system performance and column aging effects.
Area of Science:
- Analytical Chemistry
- Chromatography
Background:
- Automated High-Performance Liquid Chromatography (HPLC) systems are crucial for routine quantitative analysis.
- Ensuring the reliability and accuracy of HPLC results requires continuous monitoring of system performance and column integrity.
- Current methods often involve separate procedures for analysis and system validation, increasing time and resource demands.
Purpose of the Study:
- To develop and validate a methodology for integrated on-line qualification, validation, and stability monitoring in automated HPLC systems.
- To implement the concept of deferred standards for real-time assessment of analytical system performance.
- To investigate the impact of column aging on chromatographic separation characteristics using the deferred standard approach.
Main Methods:
- Programming automated HPLC systems with specific autosampler sequences for double injections.
- Utilizing a deferred control standard injected shortly after the sample for system monitoring.
- Incorporating an internal standard for sample quantification and a deferred standard for system control.
- Developing specific software for monitoring system performance and chromatographic data.
Main Results:
- Demonstrated the feasibility of total on-line qualification, validation, and stability monitoring.
- Established methodologies to obtain both quantitative analysis data and system validation information simultaneously.
- Successfully used the deferred standard concept to probe and monitor the effects of column aging on separation characteristics during routine analyses.
Conclusions:
- The deferred standard concept offers a robust strategy for integrated on-line monitoring in automated HPLC.
- This approach enhances the reliability and efficiency of routine HPLC analyses by providing continuous system performance and stability data.
- The methodology is effective in assessing column quality and predicting its lifespan, crucial for maintaining analytical accuracy.