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Simultaneous quantification of enalapril and enalaprilat in human plasma by high-performance liquid chromatography-tandem mass spectrometry and its application in a pharmacokinetic study.
J Pharm Biomed Anal. 2009 Jan 15; 49(1):163-7.JP

Abstract

A rapid, selective and sensitive high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method was developed to simultaneously determine enalapril and enalaprilat in human plasma. With benazepril as internal standard, sample pretreatment involved in a one-step protein precipitation (PPT) with methanol of 0.2 ml plasma. Analysis was performed on an Ultimate XB-C(18) column (50 mm x 2.1 mm, i.d., 3 microm) with mobile phase consisting of methanol-water-formic acid (62:38:0.2, v/v/v). The detection was performed on a triple quadrupole tandem mass spectrometer by multiple reaction-monitoring (MRM) mode via electrospray ionization (ESI) source. Each plasma sample was chromatographed within 2.5 min. The linear calibration curves for enalapril and enalaprilat were both obtained in the concentration range of 0.638-255 ng/ml (r(2) > or = 0.99) with the lower limit of quantification (LLOQ) of 0.638 ng/ml. The intra-day precision (R.S.D.) was below 7.2% and inter-day R.S.D. was less than 14%, while accuracy (relative error R.E.) was within +/-8.7 and +/-5.5%, determined from QC samples for enalapril and enalaprilat which corresponded to requirement of the guidance of FDA. The HPLC-MS/MS method herein described was fully validated and successfully applied to the pharmacokinetic study of enalapril maleate capsules in 20 healthy male volunteers after oral administration.

Authors+Show Affiliations

Department of Analytical Chemistry, Shenyang Pharmaceutical University, Wenhua Road 103#, Shenyang 110016, PR China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

19046843

Citation

Lu, Shan, et al. "Simultaneous Quantification of Enalapril and Enalaprilat in Human Plasma By High-performance Liquid Chromatography-tandem Mass Spectrometry and Its Application in a Pharmacokinetic Study." Journal of Pharmaceutical and Biomedical Analysis, vol. 49, no. 1, 2009, pp. 163-7.
Lu S, Jiang K, Qin F, et al. Simultaneous quantification of enalapril and enalaprilat in human plasma by high-performance liquid chromatography-tandem mass spectrometry and its application in a pharmacokinetic study. J Pharm Biomed Anal. 2009;49(1):163-7.
Lu, S., Jiang, K., Qin, F., Lu, X., & Li, F. (2009). Simultaneous quantification of enalapril and enalaprilat in human plasma by high-performance liquid chromatography-tandem mass spectrometry and its application in a pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis, 49(1), 163-7. https://doi.org/10.1016/j.jpba.2008.10.012
Lu S, et al. Simultaneous Quantification of Enalapril and Enalaprilat in Human Plasma By High-performance Liquid Chromatography-tandem Mass Spectrometry and Its Application in a Pharmacokinetic Study. J Pharm Biomed Anal. 2009 Jan 15;49(1):163-7. PubMed PMID: 19046843.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Simultaneous quantification of enalapril and enalaprilat in human plasma by high-performance liquid chromatography-tandem mass spectrometry and its application in a pharmacokinetic study. AU - Lu,Shan, AU - Jiang,Kun, AU - Qin,Feng, AU - Lu,Xiumei, AU - Li,Famei, Y1 - 2008/10/22/ PY - 2008/07/12/received PY - 2008/10/05/revised PY - 2008/10/10/accepted PY - 2008/12/3/pubmed PY - 2009/4/3/medline PY - 2008/12/3/entrez SP - 163 EP - 7 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 49 IS - 1 N2 - A rapid, selective and sensitive high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method was developed to simultaneously determine enalapril and enalaprilat in human plasma. With benazepril as internal standard, sample pretreatment involved in a one-step protein precipitation (PPT) with methanol of 0.2 ml plasma. Analysis was performed on an Ultimate XB-C(18) column (50 mm x 2.1 mm, i.d., 3 microm) with mobile phase consisting of methanol-water-formic acid (62:38:0.2, v/v/v). The detection was performed on a triple quadrupole tandem mass spectrometer by multiple reaction-monitoring (MRM) mode via electrospray ionization (ESI) source. Each plasma sample was chromatographed within 2.5 min. The linear calibration curves for enalapril and enalaprilat were both obtained in the concentration range of 0.638-255 ng/ml (r(2) > or = 0.99) with the lower limit of quantification (LLOQ) of 0.638 ng/ml. The intra-day precision (R.S.D.) was below 7.2% and inter-day R.S.D. was less than 14%, while accuracy (relative error R.E.) was within +/-8.7 and +/-5.5%, determined from QC samples for enalapril and enalaprilat which corresponded to requirement of the guidance of FDA. The HPLC-MS/MS method herein described was fully validated and successfully applied to the pharmacokinetic study of enalapril maleate capsules in 20 healthy male volunteers after oral administration. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/19046843/Simultaneous_quantification_of_enalapril_and_enalaprilat_in_human_plasma_by_high_performance_liquid_chromatography_tandem_mass_spectrometry_and_its_application_in_a_pharmacokinetic_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(08)00570-0 DB - PRIME DP - Unbound Medicine ER -