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Abstract

DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING UV-VIS SPECTROPHOTOMETRIC ASSAY METHOD OF DIDANOSINE BY USING DIFFERENT STRESS DEGRADATION CONDITIONS

Gauri Santosh Kulkarni*, Chandrashekhar Ashok Kale, Vitthal V.Chopade, and Pravin.D.Chaudhari

ABSTRACT

The aim of the present work is to study and develop a simple, accurate, precise and economic UV-Vis Spectrophotometric method for estimation of Didanosine in bulk and determination of percent degradation by using different stress condition. The solvent used was Distilled water and absorption maxima (λ max) of drug was found to be 248.5 nm. The linear response was observed in the range of 2-18 μg/ml with regression coefficient 0.998. The method was validated for different parameters as per International Conference for Harmonization (I.C.H.) guidelines. Didanosine was subjected to various stress degradation conditions recommended by I.C.H. Stress degradation studies were carried out to provide indications of stability indicating property of proposed method.

Keywords: Didanosine-ddI, Validation, Stress degradation studies, UV-VIS Spectroscopy.


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