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THE PHARMA REVIEW (DECEMBER 2008)

Spectrophotometric Methods for Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Tablet Dosage Form

S. S. Kadukara, P. N. Ranjanea, S. S. Ranhera, S. V. Gandhia

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 g/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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