edoc

Development and validation of a liquid chromatography/mass spectrometry method for pharmacokinetic studies of OZ78, a fasciocidal drug candidate

Kirchhofer, C. and Keiser, J. and Huwyler, J.. (2010) Development and validation of a liquid chromatography/mass spectrometry method for pharmacokinetic studies of OZ78, a fasciocidal drug candidate. Journal of chromatography B, Vol. 878, H. 28. pp. 2770-2774.

Full text not available from this repository.

Official URL: http://edoc.unibas.ch/dok/A5840215

Downloads: Statistics Overview

Abstract

Fascioliasis is a zoonotic disease of considerable public health and great veterinary significance and new drugs are needed. OZ78 is a promising fasciocidal drug candidate. In order to support the development of OZ78, including pharmacokinetic (PK) studies an accurate, precise, and selective liquid chromatography/mass spectrometry (LC/MS) method for OZ78 was developed for sheep plasma and validated in accordance with the US Food and Drug Administration Guidance on Bioanalytical Method Validation. Protein precipitation was used for sample clean up. Separation was performed through a Phenomenex C8(2) analytical column (50.0mm×2.0mm, 5?m) with a mobile phase of acetonitrile (buffer B) and 5mM ammonium formate (buffer A) at a flow-rate of 0.3mL/min and a gradient from 20% to 95% acetonitrile. The mass spectrometer was operated under selected ion monitoring, and orifice voltage set to -4.1kV and ion spray temperature to 400°C. Nitrogen was used as a nebulizer, curtain, and collision gas. OZ78 was monitored at 321.4m/z (deprotonated parent compound, M-). The validated linear dynamic range was between 156.25ng/mL and 5?g/mL and the achieved correlation coefficient (r(2)) was greater than 0.99. The validation results demonstrated that the developed LC/MS method is precise, accurate, and selective for the determination of OZ78 in sheep plasma. The method was successfully applied to the evaluation of the PK profile of OZ78 in sheep.
Faculties and Departments:03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Klinische Pharmakologie
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Klinische Pharmakologie
05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Pharmazeutische Technologie (Huwyler)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Medical Parasitology and Infection Biology > Helminth Drug Development (Keiser)
UniBasel Contributors:Huwyler, Jörg and Keiser, Jennifer and Kirchhofer, Carla
Item Type:Article, refereed
Article Subtype:Research Article
Bibsysno:Link to catalogue
Publisher:Elsevier
ISSN:0378-4347
Note:Publication type according to Uni Basel Research Database: Journal article
Related URLs:
Identification Number:
Last Modified:24 May 2013 09:03
Deposited On:08 Jun 2012 06:51

Repository Staff Only: item control page