Development and validation of an LC-MS/MS method for the quantitative determination of aripiprazole and its main metabolite, OPC-14857, in human plasma.
An accurate, sensitive, reproducible, and selective liquid chromatography/tandem mass spectrometry (LC-MS/MS) method for determination of aripiprazole and its main metabolite, OPC-14857, in human plasma was developed and validated. Chromatographic separation was achieved isocratically on a C18 reversed-phase column within 7.5 min. The calibration curve, ranging from 0.1 to 100 ng/ml, was fitted to a 1/y2-weighted linear regression model. The assay showed no significant interference. Lower limit of quantitation (LLOQ) for both analytes was 0.1 ng/ml using 0.4 ml of plasma. Intra- and inter-assay precision and accuracy values for aripiprazole and OPC-14857 were within regulatory limits.
Kubo
Masanori
M
Clinical Pharmacology, Department of Clinical Research & Development, Otsuka Pharmaceutical Co., Ltd., 3-2-27, Otedori, Chuo-ku, Osaka 540-0021, Japan. kubom@otsuka.jp
Mizooku
Yasuo
Y
Hirao
Yukihiro
Y
Osumi
Takahiko
T
D000068180:Aripiprazole; D002853:Chromatography, Liquid / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D013058:Mass Spectrometry / Q000379:methods*; D010879:Piperazines / Q000097:blood*; D015363:Quinolones / Q000097:blood*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
C504128:OPC-14857; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole