A VALIDATED STABILITY INDICATING ASSAY METHOD OF ZIDOVUDINE BY UV-VISIBLE SPECTROPHOTOMETER

Abstract

The objective of the present work was to develop a simple, precise, cost effective and accurate stability indicating assay method for Zidovudine using UV-Vis spectrophotometer under different stress conditions (hydrolytic, oxidative, photolytic and thermal) recommended by the International Conference for Harmonisation. The stress study was performed by taking distilled water as solvent and absorbance was taken at absorption maxima (λ_max) of 267nm. After performing a hydrolytic study of the drug in different conditions of acidic, alkali and neutral medium, the drug was found to be degraded very slowly about 8.7 % in highly acidic condition, 19.5% in alkali media and 5 % in neutral medium. The drug was found to be oxidized by 25.0 % in 3%, H₂O₂   solution, whereas the  drug was found to be almost stable in thermal condition but degraded by 15.8%  in photolytic condition. A linear response was observed in the range of 5-50μg/ml with a regression coefficient of 0.999. The method was validated as per the ICH (International Conference for Harmonization) guidelines. The % COV value for intermediate precision studies was < 2 indicates the good precision of the method. The % of the recovery of the drug ranged from 100.40 - 102.55 indicates the accuracy of the method for estimation of degradants in different stress conditions. The method was specific to the drug and also selective to degradation products formed under different stressed conditions.