Liquid chromatography tandem mass spectrometry assay to determine the pharmacokinetics of aildenafil in human plasma

J Pharm Biomed Anal. 2007 May 9;44(1):231-5. doi: 10.1016/j.jpba.2007.01.017. Epub 2007 Jan 17.

Abstract

A simple, sensitive and specific liquid chromatography/tandem mass spectrometry method for the quantitation of aildenafil, a new phosphodiesterase V inhibitor, in human plasma is presented. The analyte and internal standard, sildenafil, were extracted by a one-step liquid-liquid extraction in alkaline conditions and separated on a C(18) column using ammonia:10mM ammonium acetate buffer:methanol (0.1:15:85, v/v/v) as the mobile phase. The detection by an API 4000 triple quadrupole mass spectrometer in multiple-reaction monitoring mode was completed within 2.5 min. The calibration curve exhibited a linear dynamic range of 0.05-100 ng/ml with a 10 pg/ml limit of detection. The intra- and inter-day precisions measured as relative standard deviation were within 8.04% and 5.72%, respectively. This method has been used in a pharmacokinetic study of aildenafil in healthy male volunteers each given an oral administration of one of the three dosages.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetates / chemistry
  • Administration, Oral
  • Ammonia / chemistry
  • Area Under Curve
  • Buffers
  • Calibration
  • Chromatography, Liquid / instrumentation
  • Chromatography, Liquid / methods*
  • Dose-Response Relationship, Drug
  • Fasting
  • Half-Life
  • Humans
  • Hydrogen-Ion Concentration
  • Male
  • Metabolic Clearance Rate
  • Methanol / chemistry
  • Molecular Structure
  • Phosphodiesterase Inhibitors / administration & dosage
  • Phosphodiesterase Inhibitors / blood*
  • Phosphodiesterase Inhibitors / chemistry
  • Phosphodiesterase Inhibitors / classification
  • Phosphodiesterase Inhibitors / isolation & purification
  • Phosphodiesterase Inhibitors / pharmacokinetics*
  • Piperazines / administration & dosage
  • Piperazines / blood*
  • Piperazines / chemistry
  • Piperazines / pharmacokinetics*
  • Purines
  • Reference Standards
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Sildenafil Citrate
  • Sulfones / administration & dosage
  • Sulfones / blood*
  • Sulfones / chemistry
  • Sulfones / pharmacokinetics*
  • Tablets
  • Tandem Mass Spectrometry / methods*
  • Time Factors

Substances

  • Acetates
  • Buffers
  • Phosphodiesterase Inhibitors
  • Piperazines
  • Purines
  • Sulfones
  • Tablets
  • Ammonia
  • aildenafil
  • Sildenafil Citrate
  • ammonium acetate
  • Methanol