HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis technique widely used to determine purity, impurities, and degradation products of pharmaceuticals. The focus of most validation work is on the methodology and the standard operating procedure (SOP). But validation of the instrumentation and other associated items — the column, solvents, 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 are method validation and instrument validation. Failure to do so is a non-compliance in which any data is not usable or reportable. Code: FDB2324