Development and Validation of Stability-Indicating RP-UPLC Method for Simultaneous Estimation of Amlodipine Besylate and Atorvastatin Calcium in Pharmaceutical Dosage FormsDevelopment and Validation of Stability-Indicating RP-UPLC Method for Simultaneous Estimation of Amlodipine Besylate and Atorvastatin Calcium in Pharmaceutical Dosage Forms

Mallikarjuna S

doi:10.4172/2157-7064.1000187

Abstract

A stability indicating Ultra Performance Liquid Chromatography (UPLC) method was developed and validated for the simultaneous determination of Atorvastatin Calcium (ASC) and Amlodipine Besylate (AMB) in tablets. The chromatographic separation was performed on acquity UPLC, Kromasil C18, 50×2.1 mm, 3.5 μm using gradient elution of acetonitrile and 0.1% v/v Triethyl amine buffer (pH 3 ± 0.05) at flow rate of 0.8 ml/min. UV (Ultra Violet) detection was performed at 240 nm. Total run time was 2.2 min within which main compounds and degradants were separated. Stability indicating capability was established by forced degradation experiments. The method was validated for accuracy, repeatability, reproducibility and robustness. Linearity, Limit of Quantification (LOQ) and Limit of Detection (LOD) was also established.

Highlights

Amlodipine besylate [1] is a long-acting calcium channel blocker
Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-l,4-dihydro6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate
Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase

Summary

Introduction

Amlodipine besylate [1] is a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-l,4-dihydro6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is: CI O H3C O CH3 O O H3C NH C6H6O3S NH2. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42.

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