Highly sensitive liquid chromatography-tandem mass spectrometry method for quantification of a new bone anabolic agent, TAK-778, in human serum.
A liquid chromatography-tandem mass spectrometric (LC-MS-MS) method for the highly sensitive determination of a new bone-anabolic agent, TAK-778 in human serum was developed. The internal standard (I.S.) used was deuterated TAK-778. TAK-778 and I.S. were extracted from serum samples with diethyl ether at neutral pH. A turbo ion spray interface was used as the ion source of LC-MS-MS, and the analysis was performed in the selected reaction monitoring mode. The lower limit of quantification was 0.02 ng/ml when 0.4 ml of serum was used, and the standard curve was linear in the range of 0.02-10 ng/ml. The method was precise; the intra- and inter-day precision of the method was not more than 17.9%. The accuracy of the method was good with the deviations between added and calculated concentration of TAK-778 being typically within 9.0%.
Drug Analysis and Pharmacokinetics Research Laboratories, Pharmaceutical Research Division, Takeda Chemical Industries Ltd., 2-17-85 Juso-Honmachi, Yodogawa-ku, Osaka 532-8686, Japan. teshima_kouichirou@takeda.co.jp
Koichiro
K
Teshima
Takahiro
T
Kondo
Chie
C
Maeda
Tsuneo
T
Oda
Toshiaki
T
Hagimoto
Ryoichi
R
Tsukuda
Yoshinobu
Y
Yoshimura
D045930:Anabolic Agents / Q000097:blood* / Q000737:chemistry; D001582:Benzothiepins / Q000097:blood* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000706:statistics & numerical data; D006801:Humans; D013058:Mass Spectrometry / Q000379:methods / Q000706:statistics & numerical data
D045930:Anabolic Agents; D001582:Benzothiepins; C120450:TAK 778