Development And Validation Of A Robust Uv Spectrophotometric Method For The Quantitative Analysis Of Anastrozole In Bulk And CommercialFormulations

Abstract

This study reports the development and validation of a novel, cost-effective UV-visible spectrophotometric method for the quantitative estimation of anastrozole in both bulk and tablet dosage forms. The method utilizes a double-beam UV-visible spectrophotometer, with maximum absorbance observed at 210 nm using a solvent mixture of phosphate buffer saline (pH 7.4) and methanol in a 9:1 ratio. Validation was performed in accordance with ICH Q2(R1) guidelines, assessing parameters such as linearity, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). The method demonstrated excellent linearity in the concentration range of 4–20 µg/mL with a correlation coefficient (R²) of 0.9996. Accuracy results ranged from 98.04% to 100.43%, and precision studies showed low relative standard deviation (RSD), indicating high reproducibility. Sensitivity analysis yielded LOD and LOQ values of 0.5723 µg/mL and 1.7344 µg/mL, respectively. Application of the method to Femistra tablets confirmed the anastrozole content to be consistent with the labeled claims. The results establish this method as a simple, sensitive, precise, and reliable analytical approach for routine quality control of anastrozole in pharmaceutical preparations.