Synergistic Effect of BuylatedHydroxyanisole (BHA) and AscorbylPalmitate to Prevent Oxidative Degradation of Drug: A Dual Antioxidant Strategy

Abstract

Objective: The objective of this study is to investigate the synergistic effect of butylatedhydroxyanisole (BHA) and ascorbylpalmitate (AP) in preventing the oxidative degradation of a model drug. Oxidative degradation is a significant challenge in pharmaceutical formulations, leading to reduced efficacy and shelf life of drugs. BHA, a synthetic antioxidant, and AP, a lipid-soluble derivative of vitamin C, are examined for their combined effect in stabilizing drug formulations by neutralizing free radicals and delaying oxidation. Materials and Methods: A model drug sensitive to oxidative degradation was used for the study. The drug formulation was prepared with BHA, AP, and their combination at various concentrations. Control samples without antioxidants were also prepared. The samples were subjected to accelerated oxidation conditions, including exposure to light, heat, and oxygen. Drug degradation was monitored using high-performance liquid chromatography (HPLC) to quantify the remaining active pharmaceutical ingredient (API) over time. The synergistic effect of BHA and AP was assessed by comparing the degradation rates of formulations with single antioxidants and those with the combined strategy. Results and Discussion: The combination of BHA and AP exhibited a more pronounced protective effect against oxidative degradation compared to each antioxidant used individually. The HPLC analysis showed that formulations containing both BHA and AP had a significantly slower rate of drug degradation under accelerated conditions. The synergistic mechanism likely involves BHA acting as a primary antioxidant, scavenging free radicals, while AP regenerates BHA, enhancing its antioxidant capacity. This dual antioxidant strategy proved more effective in stabilizing the drug than either compound alone, suggesting an enhanced formulation stability. Conclusion: The study demonstrates that the combination of BHA and AP provides a synergistic antioxidant effect, effectively preventing oxidative degradation of the drug. This dual antioxidant strategy holds promise for enhancing drug stability, prolonging shelf life, and improving formulation performance.