Development and Validation of UV Spectrophotometric Method for Estimation of Amlodipine Besylate in Tablet Dosage Form

The present work was undertaken with an aim to develop a simple validated and cost effective UV spectroscopic method for estimation of Amlodipine besylate (AB) from different pharmaceutical formulations. The analysis was performed on wavelength maxima (λmax) 364nm and 0.1N HCl was used solvent for blank and diluents. The present method was validated as per guidelines of the International Conference on Harmonization (ICH) including parameters as linearity, accuracy, precision, reproducibility and specificity. Using this method, quantification of AB was done from different marketed formulations. Beers Lambert law was obeyed in concentration range of 1–5μg/ml and the line equation was y = 0.025X+0.0044. The mean accuracy was found to be 98.92±0.52% and 99.12±0.22%. The precision in terms of interday and intraday was evaluated and relative standard deviation (RSD) was less than 2%. The proposed method was suitable and specific to the analysis of AB even in the presence of common formulation excipients. The method was applied on two different marketed brands and AB content were 99.5±0.26 and 99.03±.61 respectively of labeled claim. The proposed method was validated as per ICH guidelines and statistically good results were obtained. The results suggest that this method can be employed for routine analysis of AB in bulk and commercial formulations