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Related Experiment Videos

System suitability in bioanalytical LC/MS/MS.

Chad J Briscoe1, Mark R Stiles, David S Hage

  • 1Department of Bioanalysis, MDS Pharma Services, Lincoln, NE 68502, USA. chad.briscoe@mdsinc.com

Journal of Pharmaceutical and Biomedical Analysis
|April 17, 2007
PubMed
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A new system suitability test for liquid chromatography tandem mass spectrometry (LC/MS/MS) ensures accurate bioanalysis data. This test identifies instrument issues missed by standard quality controls, preventing unreliable clinical sample results.

Area of Science:

  • Analytical Chemistry
  • Bioanalysis
  • Mass Spectrometry

Background:

  • System suitability is crucial for reliable bioanalytical data in regulatory submissions.
  • Liquid chromatography tandem mass spectrometry (LC/MS/MS) is a common technique in bioanalysis.
  • Existing quality control measures may not always detect subtle instrument performance issues.

Purpose of the Study:

  • To introduce and evaluate a generic system suitability test for LC/MS/MS in bioanalysis.
  • To ensure instrument performance yields accurate and reproducible data for regulatory confidence.
  • To assess the impact of system suitability failures on clinical sample analysis.

Main Methods:

  • Development of a system suitability test monitoring signal stability, carryover, and instrument response during LC/MS/MS runs.

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  • Integration of the test throughout analytical runs for over 25,000 batches of clinical samples.
  • Analysis of case studies where samples failed the proposed system suitability test despite meeting standard quality control criteria.

    • Main Results:

    • The proposed system suitability test identified instrument performance issues missed by standard quality controls.
    • In case studies, failing the system suitability test led to the rejection of batches.
    • Over 35% of clinical samples in rejected batches showed concentration changes exceeding 15% upon reanalysis.

    Conclusions:

    • The generic system suitability test is effective in detecting LC/MS/MS performance problems.
    • Poor instrument performance can significantly impact the accuracy of clinical sample concentrations.
    • Implementing this system suitability test enhances data reliability for regulatory submissions.