Development and Validation of Stability Indicating HPLC Method for the Simultaneous Analysis of Amlodipine, Hydrochlorothiazide and Valsartan in Pharmaceutical Formulation

Hypertension or high blood pressure, sometimes called arterial hypertension, is a chronic medical condition in which the blood pressure in the arteries is elevated. This requires the heart to work harder than normal to circulate blood through the blood vessels. The main factor that characterizes a rational drug combination is a synergistic action without side effects. In 2009, the US Food and Drug Administration (FDA) and the European Medicines Agency approved a triple fixed-dose combination of AML, HCT and VAL. It was found that the use of this triple combination was generally more effective in reducing blood pressure and providing overall blood pressure control than the dual combination therapies regardless of age, race, gender, ethnicity, or hypertension severity [1,2]. Amlodipine besylate (AML) is chemically described as 3-Ethyl-5methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2chlorophenyl)-l, 4-dihydro-6-methyl-3, 5pyridinedicarboxylate, monobenzenesulphonate (Figure 1A). AML tablets are formulated as white tablets equivalent to 2.5, 5, and 10 mg of AML for oral administration. AML is formulated as the besylate salt of AML, a long-acting calcium channel blocker [3].