Abstract
Objective: The objective of this research work is to develop a simple, rapid, cost-effective, accurate, precise, and robust stability-indicating reversephase ultra-high performance liquid chromatography method for the quantitative estimation of telmisartan (TEL) and amlodipine (AMD) in combined tablet dosage form.
 Methods: The method uses Poroshell 120EC-C18 column (4.6 mm × 50 mm, 2.7 μm) with an optimized mobile phase containing acetonitrile:50 mM ammonium acetate buffer in the ratio (45:55 v/v), pH adjusted to 4.5 with acetic acid. The flow rate was 0.5 ml/min, column temperature at 25°C and detection was monitored by a PDA detector at a wavelength of 245 nm. International Conference on Harmonization (ICH) recommended stress degradation studies were performed on TEL, AMD standard drugs, and tablet formulations; further stressed samples were analyzed by the proposed method.
 Results: Major degradation of TEL and AMD was observed under acidic, alkali, hydrolytic and oxidation conditions. The described method was validated as per the ICH guideline and validation parameters such as system suitability, linearity, accuracy, precision, specificity, and robustness results were within acceptable limits.
 Conclusion: The method was found to be suitable and accurate for quantitative estimation and stability study of title drugs in pharmaceutical preparations.
Highlights
Telmisartan (TEL), chemically described as 2-(4-{[4-methyl-6-(1methyl-1H-1, 3-benzoimidiazol-2-yl)-2-propyl-1H-1, 3-benzoimidazole1-yl] methyl} phenyl) benzoic acid, molecular formula C33H30N4O2 and molecular weight 514.62
AMD acts by blocking transmembrane calcium influx through the calcium channel, resulting in the relaxation of the smooth muscle in the arterial wall, decreasing peripheral resistance and reducing blood pressure
Optimization of the chromatographic conditions Chromatographic conditions were optimized with a view to developing a stability-indicating method for the simultaneous quantitative estimation of TEL and AMD
Summary
Telmisartan (TEL), chemically described as 2-(4-{[4-methyl-6-(1methyl-1H-1, 3-benzoimidiazol-2-yl)-2-propyl-1H-1, 3-benzoimidazole1-yl] methyl} phenyl) benzoic acid, molecular formula C33H30N4O2 and molecular weight 514.62. Amlodipine (AMD) is chemically described as 3-O-ethyl5-O-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)6-methyl-1,4-dihydropyridine-3,5-dicarboxylate, molecular formula C20H25ClN2O5 and molecular weight 408.88 [1,2,3] Figs. TEL is an angiotensin II receptor antagonist which helps to lower arterial hypertension by inhibiting the angiotensin-converting enzyme that converts angiotensin I into its active form angiotensin II causes vasoconstriction. AMD in contrast is a dihydropyridine-class calcium channel blocker. AMD acts by blocking transmembrane calcium influx through the calcium channel, resulting in the relaxation of the smooth muscle in the arterial wall, decreasing peripheral resistance and reducing blood pressure. Combining the angiotensin II receptor antagonist TEL with the calcium channel blocker AMD has the added benefit of reducing cardiovascular mortality and morbidity over other dual therapies while providing equivalent blood pressure control. Each antihypertensive drug has been combined with multiple other antihypertensive medications into a single pill, but this combination is unique, due to the complementary mechanisms of its components appear to enhance the effectiveness beyond that provided by each drug alone [4,5,6,7,8]
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