Quantitative determination of telmisartan, ramipril, amlodipine besylate, and atorvastatin calcium by HPLC

摘要

Telmisartan is angiotensin-II-receptor antagonist (ARA II), which is used in treatment of hypertension alone or in combination with other antihypertensive drugs such as Ramipril and Amlodipine besylate or in combination with antihyperlipidemic agent such as Atorvastatin calcium. The RP-HPLC method was developed for the assay of Telmisartan, Ramipril, Amlodipine besylate, and Atorvastatin calcium. The method was performed by reversed phase high performance liquid chromatography using a mobile phase consisting of 0.025 M potassium dihydrogen phosphate (pH 6.0):acetonitrile = 60:40, v/v, with detection at 205 nm on a BDS Hypersil C18 (250 × 4.6 mm, 5 μm i.d) at a flow rate of 1.5 mL/min in an isocratic manner. Analytical run time was 8 min. Method exhibited good linear relationship in concentration ranges (10-60, 16-96, 10-60, 10-60 μg/mL); recovery percentages (100.06, 100.85, 99.54, 100.8%); LOD (0.58, 0.16, 0.72, 0.3 μg/mL); and LOQ (1.92 0.55, 2.4, 0.98 μg/mL) for Ramipril, Telmisartan, Amlodipine besylate, and Atorvastatin calcium, respectively. Method validation was developed following the recommendations for analytical method validation of International Conference on Harmonization (ICH) and Food and Drug Administration (FDA) organizations.