Abstract
A simple, sensitive, and specific method was developed for simultaneous determination of Amlodipine besylate (AML), Valsartan (Vals) and Hydrochlorothiazide (HCT) by high performance liquid chromatography without previous separation. Satisfactory resolution was achieved using a RP-C18 chromatographic column, Phenomenex Kinetex (150 mm × 4.6 mm i.d) and a mobile phase consisting of acetonitrile-phosphate buffer (0.05 M) with pH 2.8 in the proportion of (40/60, v/v) at a flow rate 0.8 mL/min and the wavelength detection was 227 nm. The retention time for HCT, AML and VAls was 2.26, 3.16 and 11.19 min; respectively. The described method was linear over a range of 4-28 μg /ml, 5-40 μg /ml and 1-12 μg /ml for AML, Vals and HCT; respectively. The mean percent recoveries were 99.94%, 99.96% and 99.78% for AML, Vals and HCT; respectively. F-test and t-test at 95%con?dence level were used to check the intermediate precision data obtained under different experimental setups. The method could be used for analysis of combined dose tablet formulation containing AML, Vals, HCT as well as spiked human plasma.
Highlights
Amlodipine besylate (AML), 2-[(2-amino ethoxy-(methyl]-4-(2-cholophenyl)-1,4-dihydro-6-methyl-3,5-pyridine dicarboxylic acid 3-ethyl-5-methyl ester, benzosulfonate, is a potent dihydropyridine calcium channel blocker as an antihypertensive agent
Hydrochlorothiazide (HCT),6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine7-sulfonamide is used as a diuretic [1,2]
AML is official in BP, Vals is official in EP and U.S Pharmacopeia (USP), whereas HCT is official in BP and EP
Summary
Amlodipine besylate (AML), 2-[(2-amino ethoxy-(methyl]-4-(2-cholophenyl)-1,4-dihydro-6-methyl-3,5-pyridine dicarboxylic acid 3-ethyl-5-methyl ester, benzosulfonate, is a potent dihydropyridine calcium channel blocker as an antihypertensive agent. AML is official in BP, Vals is official in EP and USP, whereas HCT is official in BP and EP. These three drugs are marketed as combined dose tablet formulation in the ratio of 10:160:12.5 mg (AML:Vals:HCT). Literature survey revealed that a number of methods have been reported for estimation of AML, Vals and HCT individually or in combination with other drugs. There is very few analytical methods reported for the simultaneous analysis of these drugs in a combined dosage formulation [3,4]. The reported methods are UV spectrophotometric [5,6,7,8,9], Spectrofluorimetric [10] HPLC [11,12,13,14,15,16,17,18,19,20,21,22,23,24], HPTLC [25,26], capillary electrophoresis [27,28,29,30] and electrochemical [31,32,33,34] methods
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