11. Performance Verification of HPLC

  1. Chung Chow Chan1,
  2. Herman Lam2,
  3. Y. C. Lee3 and
  4. Xue-Ming Zhang4
  1. Herman Lam Ph.D.

Published Online: 2 MAR 2004

DOI: 10.1002/0471463728.ch11

Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification

How to Cite

Lam, H. (2004) Performance Verification of HPLC, in Analytical Method Validation and Instrument Performance Verification (eds C. C. Chan, H. Lam, Y. C. Lee and X.-M. Zhang), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/0471463728.ch11

Editor Information

  1. 1

    Eli Lilly Canada, Inc., 3650 Danforth Avenue, Toronto, Ontario M1N 2E8, Canada

  2. 2

    GlaxoSmithKline Canada, Inc., 7333 Mississauga Road North, Mississauga, Ontario L5N 6L4, Canada

  3. 3

    Patheon YM, Inc., 865 York Mills Road, Toronto, Ontario M3B 1Y5, Canada

  4. 4

    Novex Pharma, 380 Elgin Mills Road East, Richmond Hill, Ontario L4C 5H2, Canada

Author Information

  1. GlaxoSmithKline Canada, Inc., 7333 Mississauga Road North, Mississauga, Ontario L5N 6L4, Canada

Publication History

  1. Published Online: 2 MAR 2004
  2. Published Print: 15 JAN 2004

ISBN Information

Print ISBN: 9780471259534

Online ISBN: 9780471463726

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Keywords:

  • HPLC;
  • operation qualification;
  • performance qualification;
  • calibration;
  • performance verification;
  • pressure test;
  • flow rate;
  • gradient run;
  • wavelength accuracy;
  • precision;
  • accuracy;
  • linearity;
  • carry over;
  • noise;
  • draft;
  • column heater

Summary

The outcome of the chromatographic (HPLC) analysis is critically depended on the performance of the HPLC system. It is necessary to verify the performance of the HPLC is maintained within a set of pre-determined criteria to ensure the quality of the data generated by the system is reliable. The performance verification can be done by regular testing of the functionality of pump, injector, detector and column heating of the HPLC system and followed by a holistic test, which tests the whole system in which all the components are integrated together. The effects of several key performance characteristics, such as flow rate accuracy, gradient accuracy, injector precision, injector linearity, carryover, detection wavelength accuracy, linearity of detector response, detector noises and temperature control of the column heater, on the chromatography results and the tests to verify the performance are discussed in the chapter.