High performance liquid chromatographic method for simultaneous determination of fosinopril sodium and hydrochlorothiazide in tablets formulation

Authors

  • RC MASHRU Pharmacy Department. Center of relevance and excellence in NDDS. G.H. Patel building The M.S. University of Baroda. Kalabhavan, Vadodara
  • VB SUTARIYA Pharmacy Department. Center of relevance and excellence in NDDS. G.H. Patel building The M.S. University of Baroda. Kalabhavan, Vadodara
  • AJ THAKKER Pharmacy Department. Center of relevance and excellence in NDDS. G.H. Patel building The M.S. University of Baroda. Kalabhavan, Vadodara

Keywords:

Fosinopril sodium, Hydrochlorothiazide, Simultaneous determination, HPLC method

Abstract

A simple, specifi c, accurate and precise reversed phase HPLC method with UV detection for the simultaneous determinationof fosinopril sodium and hydrohclorthiazide in pharmaceutical formulations was developed. The drug solutionwas prepared in mobile phase and was injected into a C18 column with UV detection at 208 nm. The mobile phasewas a mixture of 0.2%w/v phosphoric acid in water and acetonitrile (30:70) delivered at a fl ow rate of 0.5 ml/min at29 0C. The calibration graphs were linear in the range of 10-50 μg/ml (r2 > 0.99) for fosinopril sodium and 6.25-31.35 μg/ml for hydrochlorthiazide (r2 > 0.99). The detection limit was 0.5μg/ml for fosinopril sodium and 1.0 μg/mlfor hydrochlorthiazide with quantitation limit of 10 μg/ml and 6.25 μg/ml for fosinopril sodium and hydrochlorthiazide,respectively. The statistical evaluation of the method was examined by performing intra-day (n=5) and inter-day calibration(n=5) and was found to be satisfactory, with high accuracy, and precision results. Application of the suggestedmethod was successfully applied to the simultaneous determination of fosinopril sodium and hydrochlorthiazide intablets formulation, with high percentage of recovery, good accuracy with precision.

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References

Davis R, Coukell A, Mc Tavish D. Fosinopril. A review of its pharmacology and clinical efficacy in the management of heart failure. Drugs 1997; 54: 103-116.

Shionoiri H, Naruse M, Minamisawa K, ueda S, Himeno H, Hiroto S, Takasaki I. Fosinopril. Clinical pharmacokinetics and clinical potential. Clin Pharmacokinet 1997; 32:460-480.

Kostis JB, Garland WT, Delaney C, Norton J, Liao WC. Fosinopril: pharmacokinetics and pharmacodynamics in congestive heart failure. Clin Pharmacol Ther 1995; 58: 660-665.

Ford NF, Lasseter KC, Van Harken DR, Hammett JL, Raymond R, Manning J. Single-dose and steady-state pharmacokinetics of fosinopril and fosinoprilat in patients with hepatic impairment J Clin Pharmacol 1995; 35: 145-150.

Pizarro M, Lima MJ, Domingues J, Gouveia AC, Monteiro A, Carrageta M, de Freitas AF. Antihypertensive effect of fosinopril in mild hypertension. Rev Port Cardiol 1996; 15: 495-497.

Rosolova H, Cech J, Sefrna Effectiveness and tolerance of fosinopril in the treatment of arterial hypertension of mild and medium severity. Vnitr Lek 2001; 47: 834-839.

Wang Z, Morris KR, Chu B. Aggregation behavior of fosinopril sodium-a new angiotensin –converting enzyme inhibitor. J Pharm Sci 1995; 84: 609-613.

Karpov YA. FLAG-a program of achievability of target blood pressure levels during treatment of patients with hypertension

with fosinopril. Kardiologiia 2002; 42: 52-57.

Singhvi SM, Duchin KL, Morrison RA, Willard DA, Everett DW, Frantz M. Disposition of fosinopril sodium in healthy subjects. Br J Clin Pharmacol 1998; 25: 9-15.

Schoondyke JW, Mohan R, Kelly JL, Ponder MA, Iskandar S, Douglas JE. Fosinopril-induced hepatotoxicity in a complex medical patient. Tenn Med 2002; 95: 155-156.

Parodi A, Cozzani E, Milesi G, Drosera M, Rebora A. Fosinopril as a possible pemphigus-inducing drug. Dermatology 2002; 204: 139-141.

Pahor M, Franse LV, Deitche SR, Cushman WC, Johnson KC, Shorr RI, Kottke-Marchant K, Tracy RP, Somes GW, Applegate WB. Fosinopril versus amlodipine comparative treatments study: a randomized trial to assess effects on plasminogen activator inhibitors-1. Circulation 2002; 105: 457-461.

Angulo E, Robles NR, Grois J, Barquero A, Perez Miranda M. Comparision of the antihypertensive activity of fosinopril and irbesartan. An Med Interna 2002; 19: 571-575.

Agaev MM, Azizov VA. Efficacy of combined use of fosinopril and propanolol in acute myocardial infarction. Kardiologiia 2003; 43: 29-34.

Shinghvi SM, Dunchin KL, Morrison RA, Willard DA, Everett DW, Frantz M. Disposition of fosinopril sodium in healthy subjects. Br J Clin Pharmacol 1988;25:9-15.

Krum H, Skiba M, Gilbert RE, Comparative metabolic effects of hydrochlorthiazide and indapamide in hypertensive diabetic patients receiving ACE inhibitors therapy. Diabet Med 2003; 20: 708-712.

Cremonesi G, Cavalieri L, Cikes I, Dobovisek J, Bacchelli S, Degli Esposti D, Costa FV, Borghi C, Ambrosioni E. Fixed combination of delapril plus indapamide vs fosinopril plus hydrochlorthiazide in mild to moderate essential hypertension. Adv The 2002; 19: 129-137.

Guthire R, Reggi Dr, Plesher MM, Saini RK, Battikha JP. Efficacy and safety of fosinopril/hydrochlorthiazide combinations on ambulatory blood pressure profiles in hypertension. Am J Hypertens 1996; 9: 306-311.

Hillaert S, De Grauwe K, Van den Bossche W. Simultaneous determination of hydrochlorthiazide and several inhibitors of angiotensin-converting enzyme by capillary electrophoresis. J Chromatogr A 2001; 924: 439-349.

Paraskewas D, Demetrius G. Novel flow injection spectrophotometric determination of fosinopril using UV-assisted

digestion and an orthophosphate calibration graph. Analytica Chimica Acta 2003; 481: 321-326.

Jemal M, Huang M, Mao Y, Whigan D, Schuster A. Liquid chromatography/electrospray tandem mass spectrometry method for the quantitation of fosinoprilat in human serum using automated 96-well solid-phase extraction for sample preparation. Rapid Commun Mass Sprectom 2000; 14: 1023-1028.

Erk, N. Simultaneous determination of fosinopril and hydrochlorothiazide in pharmaceutical formulations by spectrophotometric methods. J Pharm Biomed Anal 2002; 27: 901-912.

Published

2006-12-20

How to Cite

1.
MASHRU R, SUTARIYA V, THAKKER A. High performance liquid chromatographic method for simultaneous determination of fosinopril sodium and hydrochlorothiazide in tablets formulation. Ars Pharm [Internet]. 2006 Dec. 20 [cited 2024 Jul. 22];47(4):375-83. Available from: https://revistaseug.ugr.es/index.php/ars/article/view/5039

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Original Articles