HPLC Analytical Method Development and Validation
Duration: 60 Minutes
Instrumental liquid chromatography is an analysis widely used to determine purity, impurities, and the degradation products of pharmaceuticals.
The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.
Instrument Validation
- The Pumping System
- The Column
- The Detection System
- The Data System
- Accuracy
- Precision and the various measures of precision (repeatability, reproducibility, ruggedness, robustness)
- Limits of detection and Quantitation, Linearity
- Selectivity, Interferences, and Specificity
- Sensitivity
- Solution Stability
In order to meet US EPA or FDA requirements, a method must meet many stringent requirements. The more important of these specific analytical methods are method validation and instrument validation. To not do so is a non-compliance in which any data is not usable or reportable.
Chemists and Laboratory Assistants who Perform HPLC or UPLC Analyses Under GLP or ISO 17025
Dr. John C. Fetzer has been doing liquid chromatographic method development for over 35 years. His PhD was in studies of various types of chromatography. He has authored or co-authored over 50 papers on LC separations, has served on the advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry. He supervised the Good Laboratory Practices accreditation of a large research chromatography laboratory and has taught numerous short courses on GLP and ISO 17025 compliance.
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