Development and Validation of a RP-HPLC for the Simultaneous estimation of Atenolol and Hydrochlorothiazide in Pharmaceutical Dosage Forms
Keywords:
Atenolol, Hydrochlorothiazide, RP-HPLC method, Combination TabletsAbstract
The reverse phase high performance liquid chromatography (RP-HPLC) method of Atenolol and Hydrochlorothiazide is individually available in United State of Pharmacopoeia-27 (USP-27) but no reference is available for combined estimation of Atenolol and Hydrochlorothiazide in tablets formulation. The aim of our present work was to develop a precise and validated RP-HPLC method for the simultaneous determination of Atenolol and Hydrochlorothiazide in tablets formulation. The quantification was carried out by using Zorbax SB-CN (250 x 4.6 mm), 5µm column in isocratic mode with mobile phase, Water: Buffer: Methanol (50:35:15). The flow rate was 1.2 ml/min. The peak purity of Atenolol and Hydrochlorothiazide were 0.999 and 1.000 respectively. Ruggedness and robustness of method were performed and the percentage relative standard deviation (RSD) was found below 2.0%. The percentage recovery was found in the range of 98% to 102% at three different levels. Calibration curves were linear over studies ranges with correlation co-efficient found between the range of 0.99 to 1.00. Sample and standard solution stability study was performed over 21 h at room temperature and found stable. The percentage deviation was below 2.0%.
References
Os I, Hotens T, Dollerup J, Mogensen CE.
Comparison of the Combination of Enalapril and
a very low dose of Hydrochlorothiazide with
Atenolol in-patients with mild-to-moderate
Hypertension. Amer J Hypertens 1991; 10:899-
Schmieder E. Telmisartan/hydrochlorothiazide
combination therapy in the treatment of essential
hypertension. Expert Opin Pharmacother 2004;
:2303–2310.
Collins R, Peto R, MacMohan S. Blood pressure,
stroke and coronary hearth disease. Part 2, shortterm reduction in blood pressure: overview of
randomized drug trials in their epidemiological
context. Lancet 1990; 335:827-838.
Suharmi S, Santoso B, Mulyono. Influence of
atenolol on the pharma-cokinetics and diuretic
effects of hydrochlorothiazide in healthy
volunteers. Eur J Pharmacol 1990; 183:2375-
Vander Does R, Widmann L, Horrmann M,
Machwirth M, Stienen U. Suppl. Efficacy and
safety of carvedilol in comparison with atenolol
in hypertensive patients pretreated with
hydrochlorothiazide. Eur J Pharmacol 1990;
:147-152.
CVN Prasad, Parihar C, Sunil K, Parimoo P.
Simultaneous determination of Amiloride HCL,
hydrochlorothiazide and atenolol in combined
formulation by derivative Spectroscopy. J Pharm
Bio Anal 2004; 5:2303-2310.
MCF Ferraro, Castellano PM, kaufmana TS.
Chemometric determination of amiloride
hydrochloride, atenolol, hydrochlorothiazide and
timolol maleate in synthetic mixtures and
pharmaceutical formulation. J Pharm Bio Anal
; 34:305-314
Parrissi-poulou M, Reizopolou V, Kouppans M,
Machers P. Second derivative UV
Spectrophotometric determination of
hydrochlorothiazide and amiloride -
hydrochlorothiazide combination tablets. Int J
Pharma 1989; 51:169-174
Annonymous, United States Pharmacopoeia
(USP-27), Asian addition Published by the
United States Pharmacopoeia Convention Inc,
USA; 2004, p. 222-226.
Rapado-Martinez I, Garcia-Alvarez-Coque MC,
Villanueva-Camanas RM. Performance of
micellar mobile phases in reversed-phase
chromatography for the analysis of
pharmaceuticals containing beta-blockers and
other antihypertensive drugs. Analyst 1996;
:1677-1682.
Reynolds JGF, Martindale. The Extra
Pharmacopoeia, The Pharmaceutical Press, 29th
ed, London, UK, 1989, pp. 783–785.
Annonymous, British Pharmacopoeia, Published
by HMSO, London; 2008, p. 509-511.
Nevin Erk. Spectrophotometric analysis of
Hydrochlorothiazide and Valsartan. Analytical
Letters, 2002; 35: 283-302.
Bhushan R., Deepak Gupta, Shravan Kumar
Singh. Liquid chromatographic separation and
UV determination of certain antihypertensive
agents. Biomed Chromato. 2005; 20:217-224.
