Method Development and Validation (LC/MS/MS, HPLC/UV, ELISA)

A senior analytical scientist at MicroConstants developing and validating a method for a client's compound on a Waters Xevo LC/MS/MS system

Our experienced method development team specializes in developing and validating robust methods for the analysis of a wide array of compounds from small molecules to peptides.

Throughout the past decade, MicroConstants has developed over 1,400 LC/MS/MS, HPLC/UV, and ELISA methods, including more than 100 non-proprietary assay methods. We have solved difficult analytical problems including the detection of amino acids, peptides, steroids, cephalosporins, and chiral separation of various enantiomers using liquid chromatography/tandem mass spectrometry (LC/MS/MS). Read our case studies for specific examples of ways we have helped advance our clients' drug development programs.

Method Development & Validation Services

MicroConstants performs method validations, method transfers, method verifications, cross-matrix validations, full GLP validations, or any combination of them required to meet your analytical needs. All GLP methods are validated in accordance with the USFDA Guidance for Industry, Bioanalytical Method Validation.

View our list of non-proprietary assays to see if we have already developed the method you're looking for.

Techniques Available

  • LC/MS/MS (HPLC or UPLC)
  • HPLC/UV
  • Fluorescence detection
  • ELISA (EIA, LIA, FIA)

Parameters Evaluated

Bioanalytical & Immunoassay Method Validations
  • Specificity
  • Carryover *
  • Matrix effect
  • LLOQ accuracy and precision
  • Intraday accuracy and precision
  • Interday accuracy and precision
  • Extraction recovery *
  • Dilution integrity
  • Reinjection integrity *
  • Standard solution stability (benchtop and long-term)
  • Thawed sample stability
  • Freeze-thaw sample stability
  • Long-term sample stability
  • Incurred sample reproducibility during sample analysis (10%)

* Does not apply to immunoassay validations

Formulation Analysis Method Validations
  • Specificity
  • Carryover
  • Linearity
  • Homogeneity
  • Intraday accuracy and precision
  • Interday accuracy and precision
  • Standard solution stability (benchtop and long-term)
  • Freeze-thaw sample stability
  • Long-term sample stability
  • Diluted sample stability