Abstract

DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF ANTINEOPLASTIC AGENT ANASTROZOLE IN BULK AND TABLET DOSAGE FORM

Mrityunjay Banerjee*, Susanta Kumar Behera and Sujit Kumar Sahu

Abstract

A Simple U.V. Spectrophotometric method was developed for the estimation of Anastrozole in bulk and tablet dosage form by using 1N HCL. The maximum absorbance (λmax) was found to be 205.9nm. The calibration curve was in concentration range 8-18μg/ml with correlation co-efficient of 0.999. The procedure was validated as per ICH rules for accuracy, precision, detection limit, linearity, reproducibility and quantitation limit. The percentage recovery for Anastrozole was found to be 99.80% to 100.10%. Due to its simplicity, rapidness, high precision and accuracy of the method it may be used for determining Anastrozole in bulk and tablet dosage form. due its simplicity, rapidness, high precision and accuracy this method may be applied successfully for determining anastrozole in bulk and on tablet dosage formulation. The repeatability study was done for the precision of proposed method. All the results of analysis were validated according to the International Conference on Harmonization (ICH) guideline. This method has been successfully used to determine Anastrozole content in tablets of different origin and bulk mixtures.

Keywords: Anastrozole, Spectrophotometric assay.