Determination of lansoprazole in human plasma by rapid resolution liquid chromatography-electrospray tandem mass spectrometry: application to a bioequivalence study on Chinese volunteers.
A simple, sensitive and rapid LC/MS/MS method was developed for the quantification of lansoprazole in human plasma. After a simple sample preparation procedure by one-step protein precipitation with acetonitrile, lansoprazole and the internal standard bicalutamide were chromatographed on a Zorbax SB-C(18) (3.0 mm x 150 mm, 3.5 microm, Agilent) column with the mobile phase consisted of methanol-water (70:30, v/v, containing 5 mM ammonium formate, pH was adjusted to 7.85 by 1% ammonia solution). Detection was performed on a triple quadrupole tandem mass spectrometry by multiple reaction monitoring (MRM) mode via negative eletrospray ionization source (ESI(-)). The lower limit of quantification was 5.5 ng/mL, and the assay exhibited a linear range of 5.5-2200.0 ng/mL. The validated method was successfully applied to investigate the bioequivalence between two kinds of preparation (test vs. reference product) in twenty-eight healthy male Chinese volunteers.
Wu
Guo-Lan
GL
Institute of Pharmacology & Toxicology and Biochemical Pharmaceutics, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
Zhou
Hui-Li
HL
Shentu
Jian-Zhong
JZ
He
Qiao-Jun
QJ
Yang
Bo
B
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D019540:Area Under Curve; D044466:Asian People; D002138:Calibration; D002853:Chromatography, Liquid / Q000379:methods; D004355:Drug Stability; D005615:Freezing; D006207:Half-Life; D006801:Humans; D064747:Lansoprazole; D015394:Molecular Structure; D054328:Proton Pump Inhibitors; D017494:Proton Pumps / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency; D013997:Time Factors
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; D017494:Proton Pumps; D064747:Lansoprazole