Simultaneous estimation of amlodipine besylate, Rosuvastatin calcium and Fimasartan potassium trihydrate combination use
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Simultaneous estimation of amlodipine besylate, Rosuvastatin calcium and Fimasartan potassium trihydrate combination used in the treatment of hypertension using LC method Devansh A. Kansara1 · Usmangani K. Chhalotiya1 · Heta M. Kachhiya1 · Ishita M. Patel1 · Dimal A. Shah2 Received: 8 March 2020 / Accepted: 15 April 2020 © Springer Nature Switzerland AG 2020
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. Keywords Amlodipine besylate · Rosuvastatin calcium · Fimasartan potassium trihydrate · Validation · RP-LC
1 Introduction Amlodipine besylate (AML) which is chemically 3-ethyl5methyl-[(2aminoethoxy)methyl]-4(2chlorophenyl)6-methyl-1,4dihydropyridine-3,5dicarboxylate which has empirical formula C 26 H 31 ClN 2 O 8 Sand molecular weight of 567.05 gm/mole. The mechanism of action of amlodipine besylate is angio-selective calcium channel blocker which blocks the movement of calcium ions in the cardiac muscles which inhibits the contraction of cardiac muscles [1]. Rosuvastatin calcium (ROS) which is (3R, 5S, 6E)-7-(4-(4-fluorophenyl)6-(1-methylethyl)-2-(ethyl(methylsulfonyl)
amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic acid which has an empirical f ormulaC22H28FN3O6S and molecular weight is 1001.14gm/mole. The mechanism of action of Rosuvastatin calcium is an HMG Co A reductase inhibitor, HMG Co A is an a rate-limiting enzyme that converts the 3-hydroxy-3-methylglutarate to mevalonate which is indeed precursor of cholesterol synthesis, Rosuvastatin Calcium with a good and balanced diet helps to reduce LDL (Low density Lipoprotein) which are harmful for our body and helps in conserving the HDL (High density lipoprotein) [2]. Fimasartan potassium trihydrate which is chemically2(2-butyl-4-methyl-6-oxo-1-{[2′-(1H-1,2,3,4tetrazol-5-
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