Liquid chromatographic/mass spectrometric assay of rabeprazole in dog plasma for a pharmacokinetic study.
In order to evaluate the pharmacokinetic (PK) profile of rabeprazole (RA) sterile powder for injection, a rapid, sensitive and specific assay for quantitative determination of RA in dog plasma was developed and validated. After a liquid-liquid extraction procedure, samples were analyzed by liquid chromatography-electrospray ionization mass spectrometry (LC-ESI-MS) using omepazole as the internal standard (IS). The analyte and IS was chromatographed on a ZORBAX Extend-C(18) analytical column (50 x 2 mm i.d, 5 microm, Agilent Technologies, USA). The assay was linear in the range 1-2000 ng/mL. The lower limit of quantification of RA was 1 ng/mL. The recovery of RA was greater than 70%. The within- and between-batch accuracy was 102.7-107.4% and 103.5-105.7%, respectively. The plasma samples for the PK study were collected at defined time points during and after an intravenous injection (1 mg/kg) to beagle dogs and analyzed by LC-ESI-MS method. The PK parameters, such as half-life, volume of distribution, total clearance and elimination rate constant, were determined. The PK profile of RA gave insights into the application in the clinics.
Feng
Shao
S
Key Laboratory of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University, Nanjing, 210009, Jiangsu Province, People's Republic of China.
Guangji
Wang
W
Jianguo
Sun
S
Haitang
Xie
X
Hao
Li
L
Tian
Lv
L
Xiaoyan
Zhu
Z
Jingwei
Zhang
Z
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000097:blood* / Q000493:pharmacokinetics; D000818:Animals; D002853:Chromatography, Liquid / Q000379:methods*; D004285:Dogs; D004355:Drug Stability; D064750:Rabeprazole; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D064750:Rabeprazole