Abstract
A simple, rapid and reproducible HPLC method was developed for the simultaneous determination of amlodipine and valsartan in their combined dosage forms, and for drug dissolution studies. A C18 column (ODS 2, 10 μm, 200 x 4.6 mm) and a mobile phase of phosphate buffer (pH 3.6 , 0.01 mol L-1):acetonitrile: methanol (46:44:10 v/v/v) mixture were used for separation and quantification. Analyses were run at a flow-rate of 1 mL min-1 and at ambient temperature. The injection volume was 20 μL and the ultraviolet detector was set at 240 nm. Under these conditions, amlodipine and valsartan were eluted at 7.1 min and 3.4 min, respectively. Total run time was shorter than 9 min. The developed method was validated according to the literature and found to be linear within the range 0.1 - 50 μg mL-1 for amlodipine, and 0.05 - 50 μg mL-1 for valsartan. The developed method was applied successfully for quality control assay of amlodipine and valsartan in their combination drug product and in vitro dissolution studies.
Highlights
Amlodipine is a long-acting calcium channel blocker used as an anti-hypertensive agent and in the treatment of angina (Haria, Wagstaff, 1995; Murdoch, Heel, 1991)
Sahin the combination of an angiotensin receptor blocker and a calcium channel blocker constitutes an effective option for patients with hypertension (Boutouvrie et al, 2008; Plosker, Robinson, 2008)
It is a well known that validation procedure is an integral part of the analytical method development
Summary
Amlodipine (as besylate, mesylate or maleate) is a long-acting calcium channel blocker used as an anti-hypertensive agent and in the treatment of angina (Haria, Wagstaff, 1995; Murdoch, Heel, 1991). Sahin the combination of an angiotensin receptor blocker and a calcium channel blocker constitutes an effective option for patients with hypertension (Boutouvrie et al, 2008; Plosker, Robinson, 2008)
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