Validation of a liquid chromatographic-tandem mass spectrometric method for the measurement of (R)-1-[2,3-dihydro-2-oxo-1-pivaloylmethyl-5-(2-pyridyl)-1H-1,4-benzodiazepin-3-yl]-3-(3-methylaminophenyl)urea (YF476) in human plasma |
| |
Authors: | Redrup M J Leaf F C Miyashita A Watanabe T Higuchi S Chasseaud L F Cheng K N |
| |
Affiliation: | Department of Mass Spectrometry, Huntingdon Life Sciences, P.O. Box 2, Huntingdon, Cambridgeshire, PE18 6ES, UK. |
| |
Abstract: | A sensitive and specific liquid chromatographic-tandem mass spectrometric (LC-MS-MS) method has been validated for the measurement of YF476 in human plasma. The method involves a simple liquid-liquid extraction procedure, chromatography of the extracts on a C(18) column, atmospheric pressure chemical ionisation and detection in the multiple reaction monitoring mode. The calibration line was linear over the concentration range 0.1 ng/ml (the limit of quantification) to 25.0 ng/ml. Intra- and inter-batch precision was <14% and intra- and inter-batch accuracy was <11% over the entire calibration range. The bioanalytical method is robust and has been used for the analysis of many samples from human subjects involved in early clinical studies (Phase I). |
| |
Keywords: | |
本文献已被 PubMed 等数据库收录! |
|