Simultaneous determination of JTT-501 and its main metabolite in human plasma by liquid chromatography-ionspray mass spectrometry.
An LC-MS-MS analytical method was developed for the determination of a new antidiabetic agent, JTT-501 and its main metabolite (JTP-20604) in human plasma. The compounds were isolated from plasma by protein precipitation before analysis by HPLC with atmospheric pressure positive ionisation MS-MS detection. An isotopically labelled analog of JTT-501 was used as the internal standard. Linearity was demonstrated over the calibration range of about 5-10000 ng/ml for both compounds. The assay was validated with respect to accuracy, precision and analyte stability. This method was used for the determination of plasma concentrations for the two compounds in a clinical tolerability study. A cross-validation exercise between two different mass spectrometers, used for the determination of clinical samples, is also reported.
Breda
M
M
Global Drug Metabolism, Pharmacia S.p.A., Viale Pasteur 10, 20014 Nerviano, Milan, Italy. massimo.breda@pharmacia.com
Basileo
G
G
James
C A
CA
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D007004:Hypoglycemic Agents / Q000097:blood*; D007555:Isoxazoles / Q000097:blood*; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*
D007004:Hypoglycemic Agents; D007555:Isoxazoles; C112329:JTT 501