title: Quantification of pantoprazole in human plasma using LC-MS/MS for pharmacokinetics and bioequivalence study.
abstract: A highly sensitive and rapid method for the analysis of pantoprazole in human plasma using liquid chromatography coupled to tandem electrospray ionization mass spectrometry was developed. The procedure involves a simple protein precipitation method with methyl alcohol and separation by RP-HPLC. Detection was performed by positive ion electrospray ionization in multiple reaction monitoring mode, monitoring the transitions m/z 384.1→200.0 and m/z 346.1→198.0, for quantification of pantoprazole and IS, respectively. The standard calibration curves showed good linearity within the range of 5-5,000 ng mL(-1). The lower limit of quantitation (LLOQ) was about 5 ng mL(-1). The extractive recovery of pantoprazole from the biological matrix was more than 77.58% and the matrix effect was complied with relevant provision. The intra-day accuracy of the drug containing serum samples was more than 92.19% with a precision of 0.79-5.36%. The inter-day accuracy was 85.49% or more, with a precision of 0.91-12.67%. Intra and inter-day accuracy of the assay at four concentrations were 97.9-98.2% with a precision of 4.2-13.9%. This method offered good precision and accuracy and was successfully applied to the pharmacokinetic and bioequivalence studies of 40 mg of enteric-coated pantoprazole in 20 healthy Chinese volunteers.
authors.affiliation: School of Pharmacy, Nanjing Medical University, and Nanjing First Hospital, Nanjing, 210029, People's Republic of China.
authors.forename: Yun
authors.initials: Y
authors.lastname: Li
authors.forename: Mei-Juan
authors.initials: MJ
authors.lastname: Ding
authors.forename: Jing
authors.initials: J
authors.lastname: Ma
authors.forename: Shu
authors.initials: S
authors.lastname: Wang
authors.forename: Xiao-Li
authors.initials: XL
authors.lastname: Wu
authors.forename: Hui-Juan
authors.initials: HJ
authors.lastname: Xu
authors.forename: Zheng-Yu
authors.initials: ZY
authors.lastname: Lu
authors.forename: Jian-Jun
authors.initials: JJ
authors.lastname: Zou
authors.forename: Hong-Wei
authors.initials: HW
authors.lastname: Fan
authors.forename: Xue-Min
authors.initials: XM
authors.lastname: Zhou
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002138:Calibration; D002214:Capsules; D002681:China; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D006801:Humans; D008297:Male; D000077402:Pantoprazole; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D053719:Tandem Mass Spectrometry / Q000379:methods; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D002214:Capsules; D003692:Delayed-Action Preparations; D054328:Proton Pump Inhibitors; D000077402:Pantoprazole