A Validated Reversed-Phase HPLC Method for the Determination of Atorvastatin Calcium in Tablets
Journal: Austin Chromatography (Vol.1, No. 1)Publication Date: 2014-01-17
Authors : Simionato LD; Ferello L; Stamer SG; Repetto MF; Zubata PD; Segall AI;
Page : 1-4
Keywords : Atorvastatin calcium; RP-HPLC; Tablets assay;
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.
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