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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
Author(s) -
Ghosh Chinmoy,
Jain Ina,
Shinde Chandrakant P.,
Chakraborty Bhaswat S.
Publication year - 2012
Publication title -
drug testing and analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.065
H-Index - 54
eISSN - 1942-7611
pISSN - 1942-7603
DOI - 10.1002/dta.241
Subject(s) - chromatography , chemistry , electrospray ionization , mass spectrometry , selected reaction monitoring , enalaprilat , tandem mass spectrometry , metabolite , bioequivalence , liquid chromatography–mass spectrometry , solid phase extraction , extraction (chemistry) , enalapril , pharmacokinetics , pharmacology , medicine , angiotensin converting enzyme , biochemistry , radiology , blood pressure
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 C 18 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.