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Development and validation of HPLC method to quantify Zofenopril in tablet

Wafa Ben mabrouk Bouaissi, Najib Ben Hmida

Abstract


An accurate, simple, reproducible and sensitive liquid chromatographic method was developed and validated for the Zofenopril Calcium determination in tablet. The analyses were performed at room temperature on a reversed-phase Prontosil LC18 Knauer C18 column (250 mm * 4.6 mm grain size of 5 μm). The detection of the dosage form was carried out at 205 nm. The mobile phase was composed of acetonitrile: phosphate buffer (pH 2.5, 0.02 M) (80:20, v/v), and it was eluted isocratically at a 2.0 mL min-1 flow rate. The retention time for Zofenopril was found to be 4.27 min. The method was validated in terms of specificity, linearity, quantification limit, detection limit, accuracy and precision. The response was linear in the range 90 - 210 µg/mL.The correlation coefficients (R2) regression equations are greater than 0.995. The relative standard deviation values for inter-and intra-day precision are less than 2 %. Recoveries ranged between 99.34 and 100.21%. The method was successfully applied for the determination of Zofenopril in the pharmaceutical formulation.


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References


J.G. Kelly, K. O’Malley. Clinical pharmacokinetics of the newer ACE inhibitors, Clin. Pharmacokinet. 19 (1990) 177–196.

X. Liu, R.M. Engelman, J.A. Rousou, G.A. Cordis, D.K. Das. Attenuation of myocardial reperfusion injury by sulphydryl-containing angiotensin converting enzyme inhibitors, Cardiovasc. Drugs Ther. 6 (1992) 437–443.

A. Subissi, S. Evangelista, A. Giachetti. Preclinical profile of Zofenopril: an angiotensin converting enzyme inhibitor with peculiar cardioprotective properties, Cardiovasc. Drug Rev. Vol. 17, 1999, p 115–133.

Zofenopril + Hydrochlorothiazide. Summary of product characteristics, 2007. Available on request from the authors.

AF. Pasini, U. Garbin, MC. Nava and al. Effect of sulfhydryl and non-sulfhydryl angiotensin-converting enzyme inhibitors on endothelial function in essential hypertensive patients. Am J Hypertens 2007; 20: 443–450.

S. Evangelista, S. Manzini. Antioxidant and cardioprotective properties of the sulphydryl angiotensin-converting enzyme inhibitor zofenopril. J Int Med Res 2005; 33: 42–54.

C. Napoli, V. Sica, F. De Nigris, O. Pignalosa, M. Condorelli, LJ. Ignarro, A. Liguori. Sulfhydryl angiotensin-converting enzyme inhibition induces sustained reduction of systemic oxidative stress and improves the nitric oxide pathway in patients with essential hypertension. Am Heart J 2004; 148: e5.

C. Borghi, E. Ambrosioni. Survival of Myocardial Infarction Long-term Evaluation-2 Working Party. Double-blind comparison between zofenopril and lisinopril in patients with acute myocardial infarction: Results of the Survival of Myocardial Infarction Long-term Evaluation-2 (SMILE-2) Study. Am Heart J 2003; 145: 80–87.

C. Borghi, S. Bacchelli, Esposti DD, A. Bignamini, B. Magnani, E. Ambrosioni. Effects of the administration of an angiotensin-converting enzyme inhibitor during the acute phase of myocardial infarction in patients with arterial hypertension. SMILE Study Investigators. Survival of myocardial infarction long-term evaluation. Am J Hypertens 1999; 12: 665–672.

C. Borghi, S. Bacchelli, DD. Esposti, E. Ambrosioni. SMILE Study. Effects of the early ACE inhibition in diabetic nonthrombolyzed patients with anterior acute myocardial infarction. Diabetes Care 2003; 26: 1862–1868.

H. Kelbaek, E. Agner, H. Wroblewski, P. Vasehus Madsen, J. Marving. Angiotensin converting enzyme inhibition at rest and during exercise in congestive heart failure. Eur. Heart J. 1993; 14: 692–695.

PF. Binkley, GJ. Haas, RC. Starling, E. Nunziata, PA. Hatton, CV. Leier, RJ. Cody. Sustained augmentation of parasympathetic tone with angiotensin-converting enzyme inhibition in patients with congestive heart failure. J Am Coll Cardiol 1993; 21: 655–661.

P. Nilsson. Antihypertensive efficacy of zofenopril compared with atenolol in patients with mild to moderate hypertension. Blood Press 2007; 2 (suppl): 25–30.

C. Farsang. Blood pressure control and response rates with zofenopril compared with amlodipine in hypertensive patients. Blood Press 2007; 2 (suppl): 19–24.

Y. Lacourciere, P. Provencher. Comparative effects of zofenopril and hydrochlorothiazide on office and ambulatory blood pressures in mild to moderate essential hypertension. Br J Clin Pharmacol 1989; 27: 371–376.

JM. Mallion. An evaluation of the initial and long-term antihypertensive efficacy of zofenopril compared with enalapril in mild to moderate hypertension. Blood Press 2007; 2 (suppl.): 13–18.

E. Malacco, S. Piazza, S. Omboni. Zofenopril versus lisinopril in the treatment of essential hypertension in elderly patients. A randomised, double-blind, multicentre study. Clin Drug Invest 2005; 25: 175–182.

K. Narkiewicz. Comparison of home and office blood pressure in hypertensive patients treated with zofenopril or losartan. Blood Press 2007; 2 (suppl):7–12.

G. Leonetti, A. Rappelli, S. Omboni. On behalf of the Study Group. A similar 24-h blood pressure control is obtained by zofenopril and candesartan in primary hypertensive patients. Blood Press 2006; 15 (suppl 1): 18–26.

S. Kurbanoglua, M. Gumustasa, S.A. Ozkan. Simultaneous estimation and vali dation of some binary mixtures of antihypertensive drugs by RP-LC methods using two new generation silica columns. J. Pharm. Biomed. Anal.72 (2013) 198–201.

L. Sbarcea, L. Udrescu, L. Dragan, C. Trandafirescu, M. Bojita. Validated UV spectrofotometric method for quantification of zofenopril in pharmaceutical formulations. Rev. Chim. (Bucharest) 63 (2012) 562–564.

M. Jemal, E. Ivashkiv, T. Deborah, A.I. Cohen. Simultaneous determination of the prodrug zofenopril and its active drug in plasma by capillary gas chromatography-mass selective detection. J. Chromatogr. B428 (1988) 81–92.

F. Gao, D. Li, P. Ma, F. Wu. Simultaneous analysis of zofenopril and its active metabolite zofenoprilat in human plasma by LC–ESI-MS using pre-column derivatization with p-bromophenacylbromide, Chromatographia 71(2010) 1007–1014.

L. DalBo, P. Mazzucchelli, A. Marzo. Assay of zofenopril and its active metabolite zofenoprilat by liquid chromatography coupled with tandem mass spectrometry, J.Chromatogr.B749 (2000) 287–294.

F. Wu, F. Gao, L. Ding, X.M. Mao, P.C. Ma. Determination of zofenopril and its active metabolite zofenoprilat by a new derivative LC–MS method and their pharmacokinetics in healthy. Chinese volunteers, J. China Pharm. Univ. 40 (2009) 353–358.

Y. Jiang, F. Yan, B. Di, F. Feng, L. You, L. Huang, J. Lu. Development and validation of a liquid chromatography–tandem mass spectrometry method for the determination of zofenopril and its active metabolite zofenoprilat in human plasma. J. Pharm. Biomed. Anal.55 (2011) 527–532.

S.S. Aslan.Validated RP-LC method for simultaneous determination of zofenopril and hydrochlorothiazide in pharmaceutical preparations. J. Chromatogr. Sci. 49 (2011) 259–263.

G.S. Devika, M.. Sudhakar, J. VenkateshwaraRao. Isocratic RP-HPLC method for simultaneous separation and estimation of zofenopril and hydrochlorthiazide in pharmaceutical dosage forms. E-J.Chem.9 (2012) 999–1006.

ICH Q2A – Guidelines for Industry: Text on Method Validation of Analytical Procedures, March 1995.

ICH Q2B – Guidelines for Industry: Validation of Analytical Procedures: Methodology, Nov 1996.

International Conference on Harmonization of Technical Requirements for registration of pharmaceuticals for human use: Validation of analytical procedures: Text and Methodology Q2 (R1) (2005).




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