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Systematic internal standard variability and issue resolution: two case studies.

Tom Verhaeghe1

  • 1Development Bioanalysis, Janssen Research & Development, A division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.

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|October 10, 2019
PubMed
Summary
This summary is machine-generated.

High variability in internal standards for bioanalytical assays can occur due to co-eluting peaks or matrix suppression. These issues in validated assays were resolved by adjusting chromatography or sample dilution.

Keywords:
IS variabilityLC–MS/MSassay selectivityinternal standardmatrix suppression

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Area of Science:

  • Analytical Chemistry
  • Bioanalytical Method Development

Background:

  • Validated bioanalytical assays are crucial for drug development and clinical studies.
  • Internal standards are essential for accurate quantification, compensating for variations in sample preparation and instrument response.
  • High variability in internal standards can compromise assay reliability and data integrity.

Purpose of the Study:

  • To present case studies illustrating common issues with internal standards in validated bioanalytical assays.
  • To demonstrate how assay interferences can lead to high internal standard variability.
  • To provide solutions for resolving internal standard variability in complex biological matrices.

Main Methods:

  • Case study analysis of two validated bioanalytical assays exhibiting internal standard variability.
  • Investigation of interferences affecting stable isotope-labeled and structural analog internal standards.
  • Chromatographic condition optimization and sample dilution strategies were employed.

Main Results:

  • Case 1: A co-eluting peak in hepatically impaired subjects boosted the stable isotope-labeled internal standard response.
  • Case 2: Blank plasma matrix suppressed the structural analog internal standard response.
  • Both issues were successfully resolved through method adaptation and re-validation.

Conclusions:

  • Bioanalytical assay validation requires careful consideration of potential interferences affecting internal standards.
  • Chromatographic separation and appropriate sample dilution are key strategies to mitigate matrix effects and co-elution.
  • Addressing internal standard variability is critical for ensuring the accuracy and reliability of bioanalytical data.