Key result
LC-MS/MS method quantifies plasma enalapril and enalaprilat down to 1 ng/ml for bioequivalence studies.
A validated LC-MS/MS assay allows for sensitive and selective quantification of enalapril and enalaprilat in human plasma for bioavailability and bioequivalence studies.
Supports bioequivalence testing of enalapril; leaves open broader clinical adoption pending further validation.
BACKGROUND: Enalapril (EPL) is an angiotensin-converting enzyme inhibitor for the treatment of hypertension and chronic heart failure. Enalaprilat (EPLT) is an active metabolite that contributes to the overall activity of EPL. AIM: To quantitate EPL along with its metabolite EPLT using LC-MS/MS, a bioanalytical method was developed and validated with tolbutamide in human plasma using a protein precipitation technique. RESULTS: The sensitive and selective method has an LLOQ of 1 ng/ml with a linearity range of 1-500 ng/ml for both EPL and EPLT using 300 µl of plasma without any matrix effect. CONCLUSION: Linearity, specificity, accuracy, precision and stability, as well as its application to the analysis of plasma samples after oral administration of 20 mg of EPL maleate in healthy volunteers demonstrate applicability to bioavailability/bioequivalence studies.
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Halder et al. (2017) studied Healthy volunteers. Enalapril maleate was evaluated on Quantitation of enalapril and enalaprilat in human plasma. An LC-MS/MS method for quantifying enalapril and enalaprilat in human plasma demonstrated an LLOQ of 1 ng/ml and linearity of 1-500 ng/ml, proving applicable for bioequivalence studies.
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