New Stability Indicating Method for Quantification of Impurities in Amlodipine and Atorvastatin calcium Tablets by Validated HPLC

Author(s)

Eranki, R. J. V., Inti, G., Jayaraman, V., Vidiyala, S. R., Ramulu, J. S.

Author's Affiliation

Abstract

A stability indicating LC method was developed for the simultaneous determination of Amlodipine and Atorvastatin calcium in pharmaceutical dosage form. Efficient chromatographic separation was achieved on X-Select CSH, C18 4.6 x 150 mm, 3.5 µ or Equivalent  stationary phase with simple combination of a mobile phase containing Buffer : Acetonitrile : Tetrahydrofuran (575 : 400 : 25, v/v/v)with  pH 3.00 ± 0.05 using Ortho-Phosphoric Acid + 2 g of 1-Octane Sulfonic Acid Sodium Salt  delivered in an Isocratic mode and quantification was carried out using UV detection at 246 nm at a flow rate of 1.0 mL min^-1 with injection volume of 20 μl and ambient column temperature. This method is capable to detect both the drug components of Amlodipine and Atorvastatin calcium in presence of their degradation products (Amlodipine Imp-A and Atorvastatin Impurity-D, F, G and H) with detection level of 0.05 %. Amlodipine / Atorvastatin calcium in their combination drug product were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the samples were analyzed. Peak homogeneity data of Amlodipine and Atorvastatin calcium is obtained using PDA detector, in the stressed sample chromatograms, demonstrating the specificity. The method shows excellent linearity over a range of 0.05-2.0% for Amlodipine, Amlodipine Impurity-A and 0.05-1.5 % for Atorvastatin calcium and Atorvastatin calcium Impurity-D,F,G and H. The correlation coefficient for Amlodipine and Atorvastatin calcium is 1. The relative standard deviation (RSD) was always less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and the stability study of Amlodipine and Atorvastatin calcium in pharmaceutical preparations. The developed HPLC method was validated with respect to linearity, range, accuracy, precision and robustness.

Keywords

Column liquid chromatography, Method validation, Stability indicating study, Amlodipine and Atorvastatin calcium

Cite This Article

Eranki, R. J. V., Inti, G., Jayaraman, V., Vidiyala, S. R., & Ramulu, J. S. (2013). New Stability Indicating Method for Quantification of Impurities in Amlodipine and Atorvastatin calcium Tablets by Validated HPLC. International Journal for Pharmaceutical Research Scholars (IJPRS), 2(4), 458-471.