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

To support the development programme of the anti-migraine drug, frovatripta n, an analytical method using HLPC-UV was validated in rat blood and subseq uently cross-validated in dog and mouse blood to analyse samples generated from pre-clinical studies. The method was also evaluated in rabbit blood, h owever the method proved insufficiently selective/specific for this particu lar matrix A need for a more sensitive method suitable for the analysis of a large number of samples to support clinical studies was identified Advanc es in analytical technology over this period of development led to the deve lopment of IC-MS-MS analytical methods for human and rabbit whole blood tha t were appropriate for the changing requirements of each study A summary of the respective validation data, together with a discussion on the validati on procedures employed, has been presented.