Stability indicating method for simultaneous determination of polar and non-polar related compounds of Zidovudine in drug substance and drug product tablet form

Abstract

A Simple, rapid and sensitive method has been developed and validated for the determination of polar and non- polar related compounds of Zidovudine (ZVD) in drug substance and drug product. Efficient chromatographic separation was achieved on a Symmetry C18 column with a simple mobile phase combination containing a gradient mixture of solvent A and B at a flow rate of 1.0 mL min^-1 and quantitation was carried out using ultraviolet detection at 259 nm with ambient column temperature. The resolution between ZVD and its related compound-B was found to be greater than 2.2. Regression analysis shows an “r” value (correlation coefficient) greater than 0.999. This method was capable to detect all the process impurities of Zidovudine, at a level below 0.05% with respect to a test concentration of 0.50 mg mL^-1. The inter-day and intra-day precisions for all impurities of ZVD were found < 2.0% of Relative standard deviation (RSD). The method has consistent recoveries. The ZVD and its tablet form were subjected to stress conditions of acid, base, oxidative, water hydrolysis, photolysis, thermal, and humidity degradation, as prescribed by International conference on harmonization (ICH).