Abstract

DEVELOPMENT AND VALIDTION OF SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF AZILSARTAN KAMEDOXOMIL AND AMLODIPINE BESYLATE IN SYNTHETIC MIXTURE

Rathod Nidhi H.* and Dr. Paresh Patel

Abstract

A simple, economical, precise and accurate UV Spectroscopic method for simultaneous determination of azilsartan and amlodipine in synthetic mixture has been developed. First order derivative spectroscopy method (Method A) and absorbance ratio (QAbsorbance) method (Method B) were used. The amplitudes at 227.50 nm and 247.76 nm in the first order derivative spectra were selected to determine azilsartan and amlodipine respectively. Amlodipine and azilsartan show an isoabsorptive point at 230.7 nm. The second wavelength used is 248.4 nm, which is the λ-max of azilsartan. Beer’s law is obeyed in the concentration ranges of 4-32 μg/ml for both drug for derivative method as well as absorbance ratio method. The % assay in synthetic mixture was found to be in the range 99.50-100.5% for azilsartan and 98.40-99.41% for amlodipine by the proposed methods. Recovery was found in the range of 98.81-99.27% for azilsartan and 98.33-100.3% for amlodipine by first order derivative spectroscopic method and 98.33–99.83% for azilsartan and 98.68-100% for amlodipine by Q-absorbance ratio method. The results of analysis have been validated statistically and recovery studies confirmed the accuracy and reproducibility of the proposed methods which were carried out according to ICH guidelines.

Keywords: Azilsartan, amlodipine, first order derivative spectroscopy, Q- absorbance, validation.