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THE PHARMA REVIEW (DECEMBER 2008)

High Performance Thin Layer Chromatographic Method for Simultaneous Estimation of Amlodipine Besilate and Bisoprolol Fumarate in Pharmaceutical Preparations

R.B. Kakde, V.H. Kotak and D.L.Kale

Abstract: A novel analytical method for simultaneous determination of amlodipine besilate and bisoprolol fumarate in their combined dosage form has been developed by HPTLC procedure, using ethyl acetate : methanol : ammonia (6:0.5:0.5 v/v/v) as mobile phase and Merck HPTLC plate precoated 60 F254 silica gel on aluminum sheet as stationary phase.
 
Detection was carried out densitrometrically using UV detector at 229 nm. The retention factor (RF) of amlodipine besilate and bisoprolol fumarate was 0.390.02 and 0.520.02 respectively. The linear regression analysis data was used for the regression line in the range of 500-1000 ng/spot for both amlodipine besilate and bisoprolol fumarate with correlation coefficient value close to 1.0. The developed method was validated using various validation parameters such as accuracy, precision, specificity, limit of detection, limit of quantitation and ruggedness, which make method as choice for routine quality control analysis for simultaneous estimation of amlodipine besilate and bisoprolol fumarate in their combined formulation.
 
Introduction
Amlodipine (a dihydropyridine) is a calcium-channel blocker. It is given as besilate and used in the management of hypertension and angina pectoris. It is chemically 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methylpyridine-3,5- dicarboxylate monobenzenesulphonate. It is official in BP. Bisoprolol is a cardioselective beta blocker. It is given as the fumarate in the management of hypertension and angina pectoris. Chemically it is ()-1-[4-[[2-(1-methylethoxy) ethoxy] methyl] phenoxyl-3-[(1-methyl ethyl) amino]-2-propanol.It is official in USP.
 
Literature survey reveals the availability of several UV, HPLC and HPTLC methods for estimation of amlodipine besilate (AMLO) as alone or in combination with other drugs and bisoprolol fumarate (BISO) can be determined by UV, RP-HPLC, HPTLC in combination with hydrochlorthiazide and RP-HPLC as alone is reported.
 
Present work emphasizes on the quantitative estimation of amlodipine besilate and bisoprolol fumarate in their combined dosage form by HPTLC.

 

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