Determination of atorvastatin in human serum by reversed-phase high-performance liquid chromatography with UV detection

J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Nov 5;826(1-2):41-5. doi: 10.1016/j.jchromb.2005.08.008. Epub 2005 Sep 16.


A rapid and sensitive high-performance liquid chromatographic method was validated and described for determination of atorvastatin in human serum. Following liquid-liquid extraction of the drug and an internal standard (sodium diclofenac), chromatographic separation was accomplished using C18 analytical column with a mobile phase consisting of sodium phosphate buffer (0.05 M, pH 4.0) and methanol (33:67, v/v). Atorvastatin and the internal standard were detected by ultraviolet absorbance at 247 nm. The average recoveries of the drug and internal standard were 95 and 80%, respectively. The lower limits of detection and quantification were 1 and 4 ng/ml, respectively, and the calibration curves were linear over a concentration range of 4-256 ng/ml of atorvastatin in human serum. The analysis performance was studied and the method was applied in a randomized cross-over bioequivalence study of two different atorvastatin preparations in 12 healthy volunteers.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Atorvastatin
  • Chromatography, High Pressure Liquid / methods*
  • Heptanoic Acids / blood*
  • Heptanoic Acids / pharmacokinetics
  • Humans
  • Pyrroles / blood*
  • Pyrroles / pharmacokinetics
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Spectrophotometry, Ultraviolet / methods


  • Heptanoic Acids
  • Pyrroles
  • Atorvastatin