Method Development and Validation for the Estimation of Adefovir Dipivoxil in Bulk and Pharmaceutical Dosage Forms and Its Stress Degradation Studies Using UV-Vis Spectrophotometric Method: Experimental Investigation

Abstract

Objective: To develop a simple, accurate, precise, and cost-effective UV-VIS Spectrophotometric method for estimating adefovir, an anti-HIV drug, in bulk and pharmaceutical dosage form. Methods: The solvent used was methanol and the \(\lambda\)max or the absorption maxima of the drug was found to be 260 nm. Adefovir dipivoxil was subjected to stress degradation under ICH-recommended conditions. The samples generated in this manner were used in degradation studies using the developed method. Results: A linear response was observed in the range of 5- 40\(\mu\)g/ml with a regression coefficient of 0.999. The method was then validated for various parameters in accordance with the ICH (International Conference on Harmonization) guidelines. According to the stress degradation studies, Adefovir degrades in acidic and alkaline conditions but remains relatively stable when exposed to dry heat, oxidation, and photolysis. Conclusion: This method can be utilised to determine adefovir in formulation quality control without the intervention of excipients.