UPLC-MS/MS method for bioequivalence study of oral drugs of meldonium

Biomed Chromatogr. 2012 May;26(5):599-605. doi: 10.1002/bmc.1703. Epub 2011 Sep 14.


A rapid and simple method based on ultra-performance liquid chromatography on a hydrophilic interaction chromatography column with tandem mass-selective detection (UPLC-MS/MS) to determine meldonium in human plasma was developed. The calibration curve acquired in the range of 10-6000 ng/mL had quadratic form. Method validation proved the conformity of its properties (selectivity, matrix effect, lower limit of quantification, accuracy, precision and recovery) with the established requirements. The stability tests necessary for bioanalytical studies were performed. For the first time, the method was successfully applied to the bioequivalence studies of generic and brand name oral drugs of meldonium in capsules. Based on data from 24 volunteers, it was determined that the mean pharmacokinetic curves of the drugs are characterized by a double peak profile.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Area Under Curve
  • Chromatography, High Pressure Liquid / methods*
  • Cross-Over Studies
  • Drug Stability
  • Humans
  • Linear Models
  • Methylhydrazines / administration & dosage
  • Methylhydrazines / blood
  • Methylhydrazines / chemistry
  • Methylhydrazines / pharmacokinetics*
  • Middle Aged
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Tandem Mass Spectrometry / methods*
  • Therapeutic Equivalency


  • Methylhydrazines
  • 3-(2,2,2-trimethylhydrazine)propionate