A straightforward HPLC approach to testing butylated hydroxytoluene, an antioxidant, in pure and topical anti-burn gels; Evaluation of greenness, blueness, and whiteness grades

Abstract

In lieu of being used in anti-burn gels for medicinal reasons, butylated hydroxytoluene is used as a stabilizer and antioxidant to prolong the gel's lifetime and safeguard its effectiveness by halting the oxidation and degradation of other ingredients, especially fats and oils. It shields the product's texture, color, and smell against alterations brought on by light and air exposure. Antioxidants can be used to guard the product quality during the manufacturing process only and may not need to be controlled during its shelf life. A comprehensive, rapid, clear, and environmentally friendly stability-indicating liquid chromatography (LC) technique has been developed and validated, enabling the quantification of butylated hydroxytoluene levels in topical gels. The pharmaceutical compound underwent a series of evaluations in line with ICH standards. Through isocratic separation, butylated hydroxytoluene and its associated degradants were successfully distinguished. The antioxidant was quantified and validated utilizing the Kromasil C-18 stationary phase at a temperature of 45° C. The isocratic mobile phase functions at a flow rate of 2.0 mL/min. and comprises fixed proportions of filtered water, acetonitrile, and methanol. The overall AES grade of 77, AGREE grade of 0.6, AGREEprep grade of 0.6, CACI grade of 65, AGSA grade of 63.89, MoGAPI grade of 70, BAGI grade of 77.5, and ultimate whiteness of 96.3 collectively underscore the environmental benefits of the LC method. Research suggests that the proposed approach is distinctive, accurate, reliable, robust, and ecologically advantageous, rendering it appropriate for routine quality control assessments.