Research article

Rapid and sensitive liquid chromatography/tandem mass spectrometry method for simultaneous determination of enalapril and its major metabolite enalaprilat, in human plasma: Application to a bioequivalence study

  1. Chinmoy Ghosh1,2,*,
  2. Ina Jain1,
  3. Chandrakant P. Shinde2,
  4. Bhaswat S. Chakraborty1

Article first published online: 21 FEB 2011

DOI: 10.1002/dta.241

Issue

Drug Testing and Analysis

Drug Testing and Analysis

Special Issue: European Workplace Drug Testing Society 7th Symposium

Volume 4, Issue 2, pages 94–103, February 2012

Additional Information

How to Cite

Ghosh, C., Jain, I., Shinde, C. P. and Chakraborty, B. S. (2012), Rapid and sensitive liquid chromatography/tandem mass spectrometry method for simultaneous determination of enalapril and its major metabolite enalaprilat, in human plasma: Application to a bioequivalence study. Drug Test Analysis, 4: 94–103. doi: 10.1002/dta.241

Author Information

  1. 1

    Bioanalytical Department, Cadila Pharmaceuticals Limited, 1389-Trasad road, Dholka, Gujarat, India

  2. 2

    School of Studies in Chemistry, Jiwaji University, Gwalior, M.P., India

*Research Scientist, Bioanalytical Department Cadila Pharmaceuticals Limited, 1389, Trasad road, Dholka-387810, Dist—Ahmedabad, Gujarat, India.

Publication History

  1. Issue published online: 24 FEB 2012
  2. Article first published online: 21 FEB 2011
  3. Manuscript Accepted: 6 NOV 2010
  4. Manuscript Revised: 4 NOV 2010
  5. Manuscript Received: 30 JUL 2010

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Keywords:

  • enalapril;
  • enalaprilat;
  • LC-MS\MS;
  • human plasma;
  • matrix effect;
  • pharmacokinetic

A rapid and most sensitive method for simultaneous determination of enalapril (ENP) and its metabolite, enalaprilat (ENPT), in human plasma using ESI-LC-MS/MS (electrospray ionization liquid chromatography tandem mass spectrometry) positive ion multiple reactions monitoring (MRM) mode, was developed and validated. The procedure involves a simple solid-phase extraction (SPE) followed by evaporation of the sample. Chromatographic separation was carried out on a Hypurity C18 column (50 mm × 4.6 mm, 5 µm) with an isocratic mobile phase and a total run time of 2.0 min only. The MRM of ENP and ENPT is 377.10 → 234.20 and 349.20 → 206.10 respectively. The standard calibration curves showed excellent linearity within the range of 0.064 to 431.806 ng/mL for ENA and 0.064 to 431.720 ng/mL for ENPT (r ≥ 0.990). This is the only method which can quantitate upto 0.064 ng/mL for both ENP and ENPT in a single run with the shortest analysis time. In matrix effect experiment, this method shows a % CV (% coefficients of variation) of less than 5, which means that the proposed method is free from any kind of irregular ionization process.

This method was successfully applied to a pharmacokinetic study after oral administration of enalapril maleate 20 mg tablet in Indian healthy male volunteers. Copyright © 2011 John Wiley & Sons, Ltd.

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