Development and validation of a highly sensitive LC–ESI-MS/MS method for the determination of Orteronel® (TAK-700) in rat plasma: application to a pharmacokinetic study. (June 2012)

• Record Type: Journal Article
• Authors: Gurav, Sandip; Police, Anitha; Zainuddin, Mohd; Farooqui, Junaid Hassan; Reddy G, Krishna; Kethiri, Raghava Reddy; Rajagopal, Sriram; Mullangi, Ramesh
• Is Part Of: Bioanalysis. Volume 4:Number 12(2012)
• Page Start: 1471
• Page End: 1480
• Publication Date: 2012-06
• Subjects: Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio.12.107
• Languages: English
• ISSNs: 1757-6180

Abstract

Background: A highly sensitive, specific and high-throughput LC–ESI-MS/MS method in the positive mode has been developed and validated for the quantitation of Orteronel ® (TAK-700) in rat plasma using YM-55208 as an internal standard.Results: The assay procedure involves extraction of Orteronel and internal standard from rat plasma with liquid–liquid extraction method. Chromatographic separation was achieved using an isocratic mobile phase at a flow rate of 0.6 ml/min on an Atlantis dC18 column with a total run time of 2.5 min. The MS/MS ion transitions monitored were m/z 308.4→95.0 for Orteronel and m/z 262.3→194.2 for IS. Method validation was performed as per US FDA guidelines. The LLOQ achieved was 0.42 ng/ml and the linearity range extended from 0.42 to 814 ng/ml.Conclusion: The results met the acceptance criteria. The validated method was successfully applied to characterize the pharmacokinetic parameters of Orteronel in rat plasma.