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Abstract

The endeavor of the present work is to develop a simple, economical, efficient, novel green analytical method for the estimation of Amlodipine besylate, Olmesartan medoxomil and Hydrochlorothiazide in pharmaceutical formulation. Quantification was carried out using an Inertsil CN-3.5 μm (4.6 ×250 mm) column, where the mobile phase consisting of 10 mm Phosphate buffer (pH 3.0) and Acetonitrile (40:60). The flow rate was 1.0 mL/min and the effluent was monitored at 262 nm. The observed linearity was in the range of 5-25 µg/ml for Amlodipine (AMLO), Hydrochlorothiazide (HCTZ) and Olmesartan medoxomil (OLME) with a correlation coefficient of 0.997, 0.999 and 0.999 respectively. The proposed method was validated as per ICH guidelines in terms of linearity, accuracy, precision, robustness, and specificity, the limit of detection and limit of quantification. The method has been applied to Amlodipine, Hydrochlorothiazide and Olmesartan formulation without the interference of excipients of the formulation. INTRODUCTION: Amlodipine Besylate: Amlodipine Besylate (2-[(2-Aminoethoxy) methyl]-4-(2-chlorophenyl)-1, 4dihydro-6-methyl-3, 5-pyridinedicarboxylic acid 3ethyl 5-methyl ester benzene sulfonate). Amlodipine is an L-type calcium channel blocker, which decreases the contraction of action and myosin fibers in the cardiac tissue by decreasing the supply of calcium ions. This results in a significant decrease in blood pressure 1, 4-8. The chemical structure was shown in Fig. 1.

A Rapid HPLC Method for the Concurrent Determination of Several Antihypertensive Drugs from Binary and Ternary Formulations

“…Different analytical methods such as spectrophotometric [11][12][13][14][15][16][17][18], derivative spectrofluorimetric [19], HPLC [20][21][22][23][24][25][26][27], electrophoresis [28], and HPTLC [29] were reported for the concurrent determination of sartans, amlodipine, or hydrochlorothiazide from formulations and biological fluids. The literature has also reported a few analytical methods for the concurrent determination of ternary mixtures of sartans, amlodipine, and hydrochlorothiazide [30][31][32][33][34]. Furthermore, the estimation of several angiotensin II receptor antagonists with other cardiovascular drugs has been reported in the literature [35][36][37][38][39].…”