HPLC Analytical Method Development and Validation

OVERVIEW

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 column, solvents, and other reagents and chemicals is also an area of focus in an audit.

WHY SHOULD YOU ATTEND?

In order to meet US EPA or FDA requirements, a method must meet many stringent requirements. The more important of these for 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.

Participants will gain insights into the key considerations and challenges associated with method development and validation, as well as practical strategies for optimizing method performance and ensuring regulatory compliance.

AREAS COVERED

• 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
• Q & A session

TOPIC BACKGROUND

High-Performance Liquid Chromatography (HPLC) is a powerful analytical technique widely used in pharmaceutical, chemical, and biotechnology industries for the quantitative analysis of compounds. The development and validation of HPLC analytical methods are critical steps in ensuring the accuracy, reliability, and reproducibility of analytical results.