HPLC-UV determination of metformin in human plasma for application in pharmacokinetics and bioequivalence studies

J Pharm Biomed Anal. 2008 Jan 7;46(1):143-7. doi: 10.1016/j.jpba.2007.10.007. Epub 2007 Oct 13.

Abstract

In this study, a simple, rapid and sensitive HPLC method with UV detection is described for determination of metformin in plasma samples from bioequivalence assays. Sample preparation was accomplished through protein precipitation with acetonitrile and chromatographic separation was performed on a reversed-phase phenyl column at 40 degrees C. Mobile phase consisted of a mixture of phosphate buffer and acetonitrile at flow rate of 1.0 ml/min. Wavelength was set at 236 nm. The method was applied to a bioequivalence study of two drug products containing metformin, and allowed determination of metformin at low concentrations with a higher throughput than previously described methods.

Publication types

  • Clinical Trial

MeSH terms

  • Acetonitriles / chemistry
  • Administration, Oral
  • Area Under Curve
  • Calibration
  • Chemical Precipitation
  • Chromatography, High Pressure Liquid / methods*
  • Dose-Response Relationship, Drug
  • Half-Life
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / blood
  • Hypoglycemic Agents / pharmacokinetics
  • Metformin / administration & dosage
  • Metformin / blood*
  • Metformin / pharmacokinetics*
  • Reproducibility of Results
  • Spectrophotometry, Ultraviolet / methods*
  • Therapeutic Equivalency
  • Time Factors

Substances

  • Acetonitriles
  • Hypoglycemic Agents
  • Metformin