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Daily validation procedure of chromatographic assay using gaussoexponential modelling
S L Tamisier-Karolak1, M Tod, P Bonnardel
1Laboratoire de Chimie Analytique et d'Electrochimie Organiques, Faculté de Pharmacie, Chátenay-Malabry, France.
Journal of Pharmaceutical and Biomedical Analysis
|July 1, 1995
Summary
Reproducibility issues in high-performance liquid chromatography (HPLC) analysis of drugs arise from column aging. This study proposes using the exponentially modified Gaussian (EMG) model for daily validation to ensure accurate results.
Area of Science:
- Analytical Chemistry
- Chromatography Science
Background:
- High-performance liquid chromatography (HPLC) is crucial for quantifying drugs in biological samples.
- Column aging in HPLC leads to decreased reproducibility, with peak broadening and asymmetry.
- These changes necessitate adjustments in method validation criteria over time.
Purpose of the Study:
- To address the lack of reproducibility in HPLC due to column aging.
- To propose a method for daily validation criteria assessment.
- To ensure the continued quality and reliability of quantitative drug analysis.
Main Methods:
- Utilizing the exponentially modified Gaussian (EMG) model to represent chromatographic peaks.
- Studying simulated chromatographic peaks to establish relationships between measurements and EMG parameters.
- Developing procedures for daily determination of validation criteria.
Main Results:
- The study establishes a link between chromatographic measurements and EMG parameters.
- The EMG model provides a framework for understanding and quantifying peak changes.
- Simulated data analysis informs the proposed validation procedures.
Conclusions:
- The exponentially modified Gaussian (EMG) model offers a viable approach for monitoring HPLC column performance.
- Daily validation using EMG parameters can help maintain method accuracy despite column aging.
- This strategy ensures the reliability of drug quantification in biological matrices.