Development and validation of spectrophotometric method for estimation of anastrozole bulk and pharmaceutical dosage formulation

A simple, precise and accurate method was developed and validated by using a simple solvent system for anastrozole bulk and tablet dosage form. In the developed method, water and ethanol are used as solvents. The λmax was determined to be 221nm. The procedure was validated as per ICH rules for Accuracy, Precision, Detection limit, Linearity, Reproducibility and Quantitation limit. The linearity concentration range was 40-60μg/mL with the correlation coefficient of 0.9971. The percentage recovery for anastrozole was found to be 98.6 to 100.8%. Limit of detection and limit of quantitation values were found to be 1μg/mL and 3μg/mL. The method has been successfully used to analyze commercial solid dosage containing 1mg of anastrozole with good recoveries and proved to be robust. Keywords: Anastrozole, Spectrophotometer, Method development, Validation