title: Determination of Sodium Tanshinone IIA Sulfonate in human plasma by LC-MS/MS and its application to a clinical pharmacokinetic study.
abstract: An assay based on protein precipitation and liquid chromatography-tandem mass spectrometry (LC-MS/MS) has been developed and validated for the quantitative analysis of Sodium Tanshinone IIA Sulfonate (STS) in human plasma. After the addition of dehydroepiandrosterone-D5-3-sulfate sodium salt (DHEAS-D5) as internal standard (IS) and formic acid, plasma samples were prepared by one-step protein precipitation with a mixture of acetonitrile and methanol. Isocratic mobile phase consisted of 0.4 mmol/L ammonium formate buffer (16 ppm formic acid)/acetonitrile (40/60, v/v) on a XSELECT™ HSS T3 column. Detection was performed on a triple-quadrupole mass spectrometer utilizing an electrospray ionization (ESI) interface operating in positive ion and selected reaction monitoring (SRM) mode with the precursor to product ion transitions m/z 373.3→357.1 for STS and m/z 373.0→97.8 for the IS. Calibration curves of STS in human plasma were linear (r=0.9957-0.9998) over the concentration range of 2-1000 ng/mL with acceptable accuracy and precision. The lower limit of quantification in human plasma was 2 ng/mL. The validated LC-MS/MS method has been successfully applied to a pharmacokinetic study of STS in Chinese healthy male volunteers.
authors.affiliation: Department of Pharmacy, Huashan Hospital, Fudan University, Shanghai 200040, China.
authors.forename: WeiWei
authors.initials: W
authors.lastname: Qin
authors.affiliation: Department of Pharmacy, Huashan Hospital, Fudan University, Shanghai 200040, China.
authors.forename: Bin
authors.initials: B
authors.lastname: Wang
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.
authors.forename: XiaoPei
authors.initials: X
authors.lastname: Lu
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.
authors.forename: HaiMing
authors.initials: H
authors.lastname: Liu
authors.affiliation: Department of Pharmacy, Huashan Hospital, Fudan University, Shanghai 200040, China.
authors.forename: Li
authors.initials: L
authors.lastname: Wang
authors.affiliation: Department of Cardiology, Huashan Hospital, Fudan University, 12 Wulumuqi Middle Road, Shanghai 200040, China. Electronic address: qiweilin@medmail.com.cn.
authors.forename: WeiLin
authors.initials: W
authors.lastname: Qi
mesh_terms: D044466:Asian People; D002138:Calibration; D002853:Chromatography, Liquid / Q000379:methods*; D005561:Formates / Q000737:chemistry; D006801:Humans; D007202:Indicators and Reagents / Q000737:chemistry; D057230:Limit of Detection; D008297:Male; D010616:Phenanthrenes / Q000097:blood* / Q000493:pharmacokinetics*; D010949:Plasma / Q000737:chemistry*; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D005561:Formates; D007202:Indicators and Reagents; D010616:Phenanthrenes; C030544:formic acid; C024894:tanshinone II A sodium sulfonate
keywords: Human plasma; LC–MS/MS; Pharmacokinetic; Sodium Tanshinone IIA Sulfonate