Abstract
A simple, rapid, and selective HPLC-UV method was developed for the determination of antihypertensive drug substances: amlodipine besilat (AML), olmesartan medoxomil (OLM), valsartan (VAL), and hydrochlorothiazide (HCT) in pharmaceuticals and plasma. These substances are mostly used as combinations. The combinations are found in various forms, especially in current pharmaceuticals as threesome components: OLM, AML, and HCT (combination I) and AML, VAL, and HCT (combination II). The separation was achieved by using an RP-CN column, and acetonitrile-methanol-10 mmol orthophosphoric acid pH 2.5 (7 : 13 : 80, v/v/v) was used as a mobile phase; the detector wavelength was set at 235 nm. The linear ranges were found as 0.1–18.5 μg/mL, 0.4–25.6 μg/mL, 0.3–15.5 μg/mL, and 0.3–22 μg/mL for AML, OLM, VAL, and HCT, respectively. In order to check the selectivity of the method for pharmaceutical preparations, forced degradation studies were carried out. According to the validation studies, the developed method was found to be reproducible and accurate as shown by RSD ≤6.1%, 5.7%, 6.9%, and 4.6% and relative mean error (RME) ≤10.6%, 5.8%, 6.5%, and 6.8% for AML, OLM, VAL, and HCT, respectively. Consequently, the method was applied to the analysis of tablets and plasma of the patients using drugs including those substances.
Highlights
Hypertension currently affects more than 1 billion adults worldwide, and by 2025, the projected estimate is 1.5 billion [1]
Calcium channel blockers (CCBs), angiotensin receptor blockers (ARBs), angiotensin converting enzyme (ACE) inhibitors, and diuretics are generally used for hypertension therapy [2,3,4]
Olmesartan medoxomil (OLM), chemically, 5-methyl-2-oxo-2H-1,3-dioxol-4yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-({4-[2-(2H1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)-1H-imidazole-5carboxylate and valsartan (VAL) 2S-3-methyl-2-[N-({4-[2(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl) pentanamido] butanoic acid are the ARBs known as angiotensin receptor II antagonists (ARA-IIs) [6, 7]
Summary
Hypertension currently affects more than 1 billion adults worldwide, and by 2025, the projected estimate is 1.5 billion [1]. Calcium channel blockers (CCBs), angiotensin receptor blockers (ARBs), angiotensin converting enzyme (ACE) inhibitors, and diuretics are generally used for hypertension therapy [2,3,4]. Amlodipine besilate (AML), chemically, 3ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-methyl-1-dihydropyridine-3,5-dicarboxylate benzenesulfonate, is a long acting CCB [5]. Olmesartan medoxomil (OLM), chemically, 5-methyl-2-oxo-2H-1,3-dioxol-4yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-({4-[2-(2H1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)-1H-imidazole-5carboxylate and valsartan (VAL) 2S-3-methyl-2-[N-({4-[2(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl) pentanamido] butanoic acid are the ARBs known as angiotensin receptor II antagonists (ARA-IIs) [6, 7]. Hydrochlorothiazide (HCT), 6-chloro-1,1-dioxo-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide, is a diuretic substance which is often used in combination with other antihypertensive drugs such as CCBs, ACE inhibitors, or more recently ARBs [8,9,10,11].
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