~ 2442 ~ The Pharma Innovation Journal 2023; 12(2): 2442-2448 ISSN (E): 2277-7695 ISSN (P): 2349-8242 NAAS Rating: 5.23 TPI 2023; 12(2): 2442-2448 © 2023 TPI www.thepharmajournal.com Received: 21-11-2022 Accepted: 24-12-2022 Pulagurtha Bhaskararao (1) Associate Professor, Aditya Pharmacy College, Surampalem, Andhra Pradesh, India (2) ) Jawaharlal Nehru Technological University Kakinada, Kakinada, Andhra Pradesh, India Kontham Venkataramanapa Raju (1) Aditya Pharmacy College, Surampalem, Andhra Pradesh, India (2) ) Jawaharlal Nehru Technological University Kakinada, Kakinada, Andhra Pradesh, India Balla Sujiya (1) Aditya Pharmacy College, Surampalem, Andhra Pradesh, India (2) ) Jawaharlal Nehru Technological University Kakinada, Kakinada, Andhra Pradesh, India Corresponding Author: Pulagurtha Bhaskararao (1) Associate Professor, Aditya Pharmacy College, Surampalem, Andhra Pradesh, India (2) ) Jawaharlal Nehru Technological University Kakinada, Kakinada, Andhra Pradesh, India Method development and validation for the simultaneous estimation of amlodipine besylate and atorvastatin calcium in pharmaceutical dosage forms by micellar liquid chromatography Pulagurtha Bhaskararao, Kontham Venkataramanapa Raju and Balla Sujiya Abstract The present study is aimed at developing and validating an accurate, precise, linear and robust micellar liquid chromatographic method for the simultaneous estimation of amlodipine besylate (AB) and atorvastatin calcium (AC) in pharmaceutical dosage forms. The analysis of AB and AC is done with a mixture of n-butanol and polysorbate 20 (0.05 M) in the ratio of 30:70 (v/v) as mobile phase and Phenomenex C18 column (150 mm × 4.6 mm, 5 μm) as stationary phase. The chromatographic peaks of AB and AC were detected and measured at 240 nm. The retention times of AB and AC were found to be 3.61 min and 6.53 min, respectively. The developed method is demonstrated to access its suitability for meeting its intended purpose by the validation with a set of validation parameters as per ICH and USP guidelines. The method is proved to be linear from 5 to 50 μg/ml for AB and 10 to 100 μg/ml for AC with the correlation coefficients of 0.9995 and 0.9990, respectively. The method is found to be precise with percent relative standard deviation value in range 0.8-1.1% and 0.5-1.0% and accurate with recoveries of 99.20 to 101.20% and 98.80 to 100.67% for AB and AC respectively. Keywords: Amlodipine besylate, atorvastatin calcium, polysorbate 20, micellar liquid chromatography, stability indicating, analysis Introduction Amlodipine besylate (AB), chemically called as (3-ethyl 5-methyl 2-[(2aminoethoxy o methyl]-4-(2chlorophenyl)-methyl 1,4 dihydropyridine,3,5dihydrocarboxylate), is a dihydropyridine and long-acting potent calcium channel blocker used for the treatment of hypertension, congestive heart failure and angina pectoris [1] . AB lowers the blood pressure, relaxes the heart muscles and dilates the heart blood vessels to prevent spasm [2, 3] . Chemical structure of AB is given in Fig 1. Atorvastatin calcium (AC), described chemically as ([R-(R*, R*)]-2-(4-fluorophenyl)-β, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl] -1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate). AC is an antihyperlipidemic agent belonging to drug class statins [3] . AC is widely used in the treatment of hypercholesterolemia. AC decreases the levels of low-density lipoproteins and triglycerides to a major extent and slightly increases the level of high-density lipoprotein [4] . Chemical structure of AC is given in Fig 1. Fig 1: Structure of amlodipine besylate and atorvastatin calcium