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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
0.39±0.02 and 0.52±0.02 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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