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Abstract: This work is concerned with the
determination of Olmesartan medoxomil and
Hydrochlorothiazide in marketed formulation by
simultaneous equation method, absorbance correction
method and area under the curve method. The linearity
was found in the range 8-40 g/mL and 4-20 µg/mL for
Olmesartan medoxomil and Hydrochlorothiazide
respectively for all the three methods. The developed
three spectrophotometric methods were validated
statistically and can be used for routine simultaneous
determination of these drugs in quality control
laboratories.
Introduction
Olmesartan medoxomil (OM, 2, 3-dihydroxy-2-butenyl
4-(1-hydroxy-1-Methyl ethyl)-2-propyl-1- [p-
(o-1H-tetrazol-5-ylphenyl) benzyl]
imidazole-5-carboxylate, cyclic 2, 3-carbonate) is a
selective AT1 subtype angiotensin II receptor
antagonist.1 Hydrochlorothiazide (HTZ,
6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulphonamide-1,1-dioxide)
is a diuretic antihypertensive agent.
Extensive literature survey revealed UV-Vis
spectrophotometric determination of OM in pharmaceutical
dosage form. HPLC-MS4 and LC-MS5 determination of OM has
also been reported in biological samples. Several assay
methods have been reported for determination of HTZ in
pharmaceutical dosage form or in biological samples as a
single or in combination with other drugs. These include
spectrophotometry, RP-HPLC, HPLC-Narrowbore
chromatography, HPTLC and electrochemical study. Also
stability-indicating LC method has been reported for HTZ
determination in combination with ramipril. No reports
were found for simultaneous spectrophotometric
determination of OM and HTZ in combined tablet dosage
form.
Aim of the present work was to develop simple,
economical, rapid, accurate and precise
spectrophotometric methods for determination of OM in
combination with HTZ in pharmaceutical formulation. The
proposed methods were optimized and validated as per the
International Conference on Harmonization (ICH)
guidelines.
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