Stability Indicating Method Development and Validation of Candesartan in Bulk and Pharmaceutical Dosage Form by Derivative Spectrophotometric Method (First Order)

Abstract

A simple method for the estimation of candesartan in bulk and pharmaceutical dosage forms has been developed. Methanol was chosen as the solvent system. The λdet was found to be 268.8 nm. The responses were linear in the range of 10 - 20 μg/ml. The regression equation of the calibration graph and correlation coefficient were found to be y = 0.001x – 0.002 and 1 respectively. The % RSD values for both intraday and interday precision were less than 2%. The recovery of the drug from the sample was found to be 100%. The proposed method was validated for precision, accuracy, intraday and interday assay. Commercial formulation used was candesartan SMEDDS, it was analyzed by the proposed method and the results were well within the claimed limits. Further stability studies of candesartan were carried out under acidic, alkaline, hydrolytic, oxidative and photolytic conditions as per SIAM (Stability Indicating Assay Methods) as described by International Conference on Harmonisation. Keywords: Candesartan, UV method development, UV derivative spectroscopy, first order, Validation studies, Stability assay.