A Validated Reversed-Phase HPLC Method for the Determination of Atorvastatin Calcium in Tablets

Research Article

Austin Chromatogr. 2014;1(1): 4.

A Validated Reversed-Phase HPLC Method for the Determination of Atorvastatin Calcium in Tablets

Simionato LD, Ferello L, Stamer SG, Repetto MF, Zubata PD and Segall AI*

Facultad de Farmaciay Bioquímica, Universidad de Buenos Aires, Argentina

*Corresponding author: Segall AI, Cátedra de Calidad de Medicamentos, Facultad de Farmaciay Bioquímica, Universidad de Buenos Aires, CONICET, Junín 956, 1113 Buenos Aires, Argentina

Received: August 25, 2014; Accepted: September 12, 2014; Published: September 17, 2014

Abstract

A Reversed-Phase Liquid Chromatographic (RP-LC) assay method was developed for the quantitative determination of atorvastatin calcium in the presence of its degradation products. The assay involved an isocratic elution of atorvastatin calcium in a LiChroCARTR 250*4 mm HPLC Cartridge LiChrospherR 100 RP-18 (5 μm) column using a mobile phase consisting of 0.1% acetic acid solution: acetonitrile (45:55, v/v), pH = 3.8. The flow rate was 0.8 mL/min and the analytes monitored at 246 nm. The assay method was found to be linear from 8.13 to 23.77 μg/mL. All the validation parameters were within the acceptance range. The developed method was successfully applied to estimate the amount of atorvastatin calcium in tablets.

Keywords: Atorvastatin calcium; RP-HPLC; Tablets assay

Introduction

Atorvastatin, 1H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)-β, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), trihydrate [R-(R*,R*)]-; (Figure 1) is a statin group medicine that reduces the level of serum cholesterol; thus it is used to treat hypercholesterolemia. Independent of the cholesterol-lowering property of statins they also have anti-inflammatory and immunomodulating effects. It is rapidly absorbed from the gastro-intestinal tract. It has low absolute bioavailability of about 12% due to presystemic clearance in the gastro-intestinal mucosa and/or first pass metabolism in the liver, its primary site of action. Atorvastatin is metabolized by cytochrome P450 3A4 to a number of compounds which are also active inhibitors of HMG-CoA reeducates. The mean plasma elimination half-life of inhibitory activity for HMG-CoA reeducates is approximately 20 to 30 hours due to the contribution of the active metabolites. It is 98% bound to plasma proteins. Atorvastatin is excreted as metabolites, primarily in the bile [1].