HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the 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 the column, solvents, and other reagents and chemicals is also an area of focus in an audit.

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.

AREAS COVERED IN THE SESSION:

Instrument validation

• The Pumping System
• The Column
• The Detection System
• The Data System

Method Validation

• 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

WHO SHOULD ATTEND:

• Chemist
• Laboratory Assistants
• QA Managers and Personnel
• QC Managers and Personnel
• Validation Specialists
• Quality System Auditors
• Regulatory Compliance Associates

Course Director: Dr. JOHN C. FETZER

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.