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

Author(s)

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

Author's Affiliation

Abstract

A stability indicating LC method was developed for the simultaneous determination of amlodipine and hydrochlorothiazide in pharmaceutical dosage form.  Efficient chromatographic separation was achieved on Zorbax SB Phenyl stationary phase with simple combination of a mixture contained mobile phase (1 ml of methane sulfonic acid in to 1000 ml of DI Water) and Acetonitrile in the ratio of 65:35 v/v respectively, delivered in an Isocratic mode and quantification was carried out using ultraviolet detection at 210 nm at a flow rate of 1.0 mL min^-1 with Injection Volume of 10 μl and Column temperature at 40°C. In the developed Isocratic method the separation was achieved the between all the specified analytes (Hydrochlorothiazide, Amlodipine and the potential degradation products Amlodipine Impurity-A and Hydrochlorothiazide Impurity-A) and were found to have greater than resolution 1.0 and correlation coefficient of greater than 0.999 was found for  the specified known impurities (using Amlodipine and Hydrochlorothiazide standard responses). This method was capable to detect both the drug components of Amlodipine and Hydrochlorothiazide in presence of their degradation products (Amlodipine Imp-A and Hydrochlorothiazide Impurity-A) with the detection level of 0.05 %. 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 Hydrochlorothiazide

Cite This Article

Eranki, R. J. V., Inti, G., Jayaraman, V., Vidiyala, S. R., & Jadi, S. (2014). New Stability Indicating Method for Quantification of Impurities in Amlodipine and Hydrochlorothiazide Tablets by Validated HPLC. International Journal for Pharmaceutical Research Scholars (IJPRS), 3(2), 591-601.