Simultaneous estimation of amlodipine besylate, Rosuvastatin calcium and Fimasartan potassium trihydrate combination used in the treatment of hypertension using LC method

Abstract

The proposed sensitive, precise, and accurate reverse phase-liquid chromatography (RP-LC) method is used for simultaneous estimation Amlodipine besylate, Rosuvastatin calcium and Fimasartan potassium trihydrate in bulk and synthetic mixture which is under phase 3 trial. An accurate and cost effective isocratic approach is employed by using Phenomenex C-18 column (250 mm × 4.6 mm, 5 μm). A method was developed and validated by focusing on ICH Q2 (R1) guideline parameters, efficient separation of all three drugs were obtained by optimised solvent mixture of acetonitrile and 0.02 M potassium dihydrogen phosphate buffer (49:51, v/v) pH 3.0 adjusted with 1% O—phosphoric acid used as mobile phase, flow rate was maintained 1 ml/min and analysis was carried out by using PDA detector at common wavelength 242 nm. The linearity ranges were found to be 1–7 μg/mL for Amlodipine besylate with correlation coefficient (r2) 0.9966, 2–12 μg/mL for Rosuvastatin calcium with correlation coefficient (r2) 0.9998 and 6–36 μg/mL for Fimasartan potassium trihydrate with correlation coefficient (r2) 0.9990, respectively. The proposed LC method has potential qualitative as well as quantitative applications for simultaneous estimation of Amlodipine besylate, Rosuvastatin calcium and Fimasartan potassium trihydrate in bulk and synthetic mixture.