Chromatographia

, Volume 52, Supplement 1, pp S113–S119 | Cite as

Development of an analytical methodology from toxicokinetic to clinical studies for the anti-migraine drug frovatriptan

  • L. Laugher
  • R. Briggs
  • J. Doughty
  • T. A. G. Noctor
Particular Analytes

Summary

To support the development programme of the anti-migraine drug, frovatriptan, an analytical method using HLPC-UV was validated in rat blood and subsequently cross-validated in dog and mouse blood to analyse samples generated from pre-clinical studies. The method was also evaluated in rabbit blood, however the method proved insufficiently selective/specific for this particular matrix. A need for a more sensitive method suitable for the analysis of a large number of samples to support clinical studies was identified. Advances in analytical technology over this period of development led to the development of LC-MS-MS analytical methods for human and rabbit whole blood that were appropriate, for the changing requirements of each study. A summary of the respective validation data, together with a discussion on the validation procedures employed, has been presented.

Key Words

Column liquid chromatography LC-MS/MS Validation Frovatriptan Anti-migraine drug 

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Copyright information

© Friedr. Vieweg & Sohn Verlagsgesellschaft mbH 2000

Authors and Affiliations

  • L. Laugher
    • 1
  • R. Briggs
    • 2
  • J. Doughty
    • 3
  • T. A. G. Noctor
    • 4
  1. 1.Department of Biopharmaceutical AnalysisCovance LaboratoriesHarrogateUK
  2. 2.Vernalis LimitedGuildfordUK
  3. 3.Covance Clinical Research UnitProject Management GroupLeedsUK
  4. 4.York Bioanalytical Solutions Limited, Genesis TwoYork University Science ParkHeslingtonUK

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