title: Determination of pitavastatin in human plasma via HPLC-ESI-MS/MS and subsequent application to a clinical study in healthy Chinese volunteers.
abstract: BACKGROUND
  Pitavastatin is a novel statin used in the treatment of hyperlipemia. We developed and describe a simple and rapid high performance liquid chromatography-electrospray tandem mass spectrometry (HPLC-ESI-MS/MS) assay for the determination of pitavastatin in human plasma.
  
  
  METHODS
  A Finnigan TSQ Quantum Discovery max system equipped with an electrospray ionization source and a Finnigan Surveyortrade mark HPLC system (Thermo Electron, San Jose, CA) was used employing lovastatin as internal standard (IS) for pitavastatin. This method entailed a single step of liquid-liquid extraction with ether from 200 microL plasma. The analyte and internal standard were baseline separated on a Gemini analytical column. Quantitation by SRM analysis was performed in the positive ion mode.
  
  
  RESULTS
  HPLC-ESI-MS/MS method validation by means of determination of limit of detection (LOD 0.05 ng/ml), lower limit of quantification (LLOQ 0.1 ng/ml), linearity (0.2-200 ng/ml). The intra-and inter-day precision CVs was <10%, and accuracy ranged from 85 to 115%. The proposed method enables the unambiguous identification and quantification of pitavastatin for clinical studies.
  
  
  CONCLUSIONS
  A sensitive and specific method for quantifying Pitavastatin levels in human plasma has been devised and successfully applied to a clinic pharmacokinetic study of pitavastatin administered.
authors: Key laboratory of Drug Metabolism and Pharmacokinetics, Nanjing, Jiangsu, China Pharmaceutical University, China.
authors: Hua
authors: H
authors: Lv
authors: Jian-Guo
authors: JG
authors: Sun
authors: Guang-Ji
authors: GJ
authors: Wang
authors: Xiao-Yan
authors: XY
authors: Zhu
authors: Ying
authors: Y
authors: Zhang
authors: Sheng-Hua
authors: SH
authors: Gu
authors: Yan
authors: Y
authors: Liang
authors: Jie
authors: J
authors: Sun
mesh_terms: D000284:Administration, Oral; D000328:Adult; D044466:Asian People; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002985:Clinical Protocols; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011804:Quinolines / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D014838:Volunteers
chemical_list: D004791:Enzyme Inhibitors; D011804:Quinolines; C108475:pitavastatin