A quick and Sensitive Liquid Chromatography–Tandem Mass Spectrometry (LC-MS) Method for the Determination of Enalapril and Enalaprilat in Human Plasma: A pplication to a Bioequivalence Study Enalapril and Enalaprilat assay in plasma
Iranian Journal of Pharmaceutical Sciences,
Vol. 12 No. 1 (2016),
15 January 2016
,
Page 21-34
https://doi.org/10.22037/ijps.v12.40785
Abstract
A rapid and sensitive liquid chromatography–tandem mass spectrometry (LC-MS) method was developed for the estimation of enalapril and enalaprilat in human plasma. Detection of analytes was achieved by tandem mass spectrometry with electrospray ionization (ESI) interface in positive ion mode was operated under the multiple-reaction monitoring mode. Sample pretreatment involved in a one-step protein precipitation (PPT) with percholoric acid (HClO4) of 0.15ml plasma. The reconstituted samples were chromatographed on C18 column by pumping methanol: water: acid formic74:24:2 (v/v) at a flow rate of 0.2 mL/min. Each plasma sample was chromatographed within 1.25 min. The standard curves were found to be linear in the range of 0.1–20 ng/mL for enalapril and enalaprilat with mean correlation coefficient of ≥0.999 for each analyte. The intra-day and inter-day precision and accuracy results were well within the acceptable limits. The limit of quantification (LOQ) was 0.1 ng/ml for enalapril and enalaprilat. The mean (SD) Cmax, Tmax, AUC0–tand AUC0–∞ values of enalapril versus enalaprilat after administration of the 10 mg enalapril are 141.33(3.51) versus73.33 (5.03) ng/mL, 1.15(1.45) versus 4.12 (1.74) hours, 142.57 (34.34) versus 425.94(13.09) ng/mL/h, and 150.74 (16.69) versus 455.80 (65.11) ng/mL/h respectively. The mean (SD) t1/2 was 2.72 (2.01) hours for the enalapril and 6.34 (2.13) hours for the enalaprilat. The developed assay method was successfully applied to a pharmacokinetic study in human male volunteers.
- Enalapril
- Enalaprilate
- Human plasma
- LC-MS
How to Cite
References
[2] Smith, D.H. Treatment of hypertension with an angiotensin II-receptor antagonist compared with an angiotensin-converting enzyme inhibitor: a review of clinical studies of telmisartan and enalapril. Clin. Ther. 24 (2002) 1484–1501.
[3] Niopas I, Daftsios A.C, Nikolaidis N. Bioequivalence study of two brands of enalapril tablets after single oral administration to healthy volunteers. Int. J. Clin. Pharmacol. Ther. 41 (2003) 226–230.
[4] Tabacova S.A, Kimmel C.A. Optimization of processing parameters for the mycelial growth. Int. J. Cariol. 25 (2005) 237–242.
[5] Shioya H, Shimojo M, Kawahara Y. Determination of enalapril and its active metabolite enalaprilat in plasma and urine by gas chromatography/mass spectrometry. Biomed. Chromatogr. 6 (1992) 59–62.
[6] Worland P.J, Jarrott B. Radioimmunoassay for the quantitation of lisinopril and enaprilat. J. Pharm. Sci. 75 (1986) 512–516.
[7] Thongnopnua P, Poeaknapo C. . Liquid chromatographic separation and UV determination of certain antihypertensive agents. J. Pharm. Biomed. Anal. 37 (2005) 763–769.
[8] Gu Q, Chen X.Y, Zhong D.F, Wang Y.W. Quantification of enalapril in human plasma by liquid chromatography –tandem mass spectrometry. J. Chromatogr. B 813 (2004) 337–342.
[9] Lee J, Son J, Lee M, Lee K.T, Kim D.H. Simultaneous quantitation of enalapril and enalaprilat in human plasma by 96-well solid-phase extraction and liquid chromatography/tandem mass spectrometry. Rapid Commun. Mass Spectrom. 17
(2003) 1157–1162.
[10] Liu C, Yang L.H, Ding L, Bian X.J. Simultaneous quantitation of enalapril and enalaprilat in human plasma by liquid chromatography/tandem mass spectrometry. Chin. J. Clin. Pharm. 15 (2006) 34–37.
[11] Yoon K.H, Kim W, Park J, Kim H.J. Quantification of enalapril in human plasma by liquid chromatography –tandem mass spectrometry.Bull. Korean Chem. Soc. 25 (2004) 878–880.
[12]. Trabelsi H, Bouabdallah S, Sabbah S, Raouafi F, Bouzouita K. Study of the cis-trans isomerization of enalapril by reversed-phase liquid chromatography. J. Chromatogr. A (2000) 871: 189.
[13]. Kocijan A, Grahek R, Kocjan D, Kralj LZ. Simultaneous quantitation of enalapril and enalaprilat in human plasma by 96-well solid-phase extraction and liquid chromatography/tandem mass spectrometry. J. Chromatogr. B (2001) 755: 229.
[14]. Walily AFME, Belal SF, Heaba EA, Kersh AE. Simultaneous determination of enalapril maleate and hydrochlorothiazide by first-derivative ultraviolet spectrophotometry and high-performance liquid chromatography. J. Pharm. Biomed. Anal. (1995) 13: 851.
[15] Qin XZ, Joe DM, Dominic PI. Determination and rotamer separation enalapril maleate by capillary electrophoresis. J. Chromatogr. A (1995) 707: 245.
[16]. Tajerzadeh H, Hamidi M. A simple HPLC method for quantitation of enalaprilat. J Pharm Biomed Anal J. Pharm. Biomed. Anal. (2001) 24: 675.
[17]. Danafar H, Hamidi M. A Rapid and Sensitive LC–MS Method for Determination ofEzetimibe Concentration in Human Plasma: Application to a Bioequivalence Study. Chromatographia (2013) 76: 1667-1675.
[18]. Danafar H, Hamidi M. Pharmacokinetics and Bioequivalence Study of Amlodipine and Atorvastatin in Healthy Male Volunteers by LC-MS. Pharmaceutical Sciences, (2015) 21(Suppl 1), 167-174
[19].Boroujerdi M. Pharmacokinetics, principles and applications, 1st ed. New York: McGraw-Hill; (2002).
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