Morten A Kall1, Morten Rohde1, Martin Jørgensen1. 1. Department of Bioanalysis, Drug ADME Research, H. Lundbeck A/S Ottiliavej 7-9, DK-2500 Valby-Copenhagen, Denmark.
Abstract
BACKGROUND: Vortioxetine is a novel antidepressant that has been developed in a joint partnership between H. Lundbeck A/S and the Takeda Pharmaceutical Company, Ltd. RESULTS: A number of bioanalytical methods have been developed in order to support the nonclinical and clinical development of the drug. Method performance, long-term stability, urine analysis, unspecific binding and metabolites analysis are presented and discussed. CONCLUSION: Two different method applications for the quantification of vortioxetine and its major human metabolite in human plasma, an isocratic cation exchange HPLC-MS/MS method utilizing C8-SPE sample extracts and a reversed-phase UPLC-MS/MS method with gradient elution of protein precipitated sample extracts, have been validated according to current regulatory standards and applied in support to a large number of nonclinical as well as clinical studies.
BACKGROUND:Vortioxetine is a novel antidepressant that has been developed in a joint partnership between H. Lundbeck A/S and the Takeda Pharmaceutical Company, Ltd. RESULTS: A number of bioanalytical methods have been developed in order to support the nonclinical and clinical development of the drug. Method performance, long-term stability, urine analysis, unspecific binding and metabolites analysis are presented and discussed. CONCLUSION: Two different method applications for the quantification of vortioxetine and its major human metabolite in human plasma, an isocratic cation exchange HPLC-MS/MS method utilizing C8-SPE sample extracts and a reversed-phase UPLC-MS/MS method with gradient elution of protein precipitated sample extracts, have been validated according to current regulatory standards and applied in support to a large number of nonclinical as well as clinical studies.
Authors: Robert L Findling; Adelaide S Robb; Melissa DelBello; Michael Huss; Nora McNamara; Elias Sarkis; Russell Scheffer; Lis H Poulsen; Grace Chen; Ole Michael Lemming; Johan Areberg; Philippe Auby Journal: J Child Adolesc Psychopharmacol Date: 2017-03-23 Impact factor: 2.576