Instrumental Issues in the Validation of HPLC/UPLC methodologies

    /John  /C Fetzerspeaker of Training Doyens
    Speaker: John C Fetzer
    Duration: 75 Minutes
    Product Code: 50023
    Level: Intermediate
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Instrumental liquid chromatography is an analysis 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.


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. Not do so, is a non-compliance in which any data is not usable or reportable.


  • Instrument validation
    • The pumping system
    • The column
    • The detection system
    • The Data System
  • Monitoring for Quality


Instrumental liquid chromatography, either as HPLC or UPLC, is common techniques in laboratories that do regulatory-compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.


Chemists and laboratory assistants who perform HPLC or UPLC analyses under GLP or ISO 17025.


John C. Fetzer has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers onl iquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.

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