Greens appraisal of validated stability indicating RP-HPLC method and forced degradation study for quantification of Ebastine in wastewater and dosage form.

Objectives: Allergic rhinitis and chronic idiopathic urticaria are common conditions triggered by environmental irritants, stress, and certain foods. The FDA has recently announced that the efficacy and safety of Ebastine (EBS) have been thoroughly evaluated and confirmed. This study considered using various tools to assess their greenness. We used AGREEprep, analytical eco-scale (ESA), and analytical method volume intensity (AMVI) to evaluate the greenness of the validated stability-indicating method and a forced degradation study. This allowed for easy determination and quantitation of EBS in wastewater and dosage form.

Methods: The method was established on Symmetry RP-C18 (150mm×4.6mm,5μm) using mobile phase, which can be prepared by mixing buffer solution of pH 3 with acetonitrile in a ratio of (37.5: 62.5, v/v) in addition to dissolving 0.72 gm of sodium lauryl sulfate in the final solution. The separation process was executed at a flow rate of 1.5mL/min and 5μL injection volume with UV detection at 254nm. Linearity was conducted for EBS in the 5-50μg/mL range. Different validation parameters were investigated, including accuracy, precision, robustness, and specificity.

Results: The limits of both detection and quantification were 0.84μg/mL and 2.57μg/mL for EBS. The recovery percentages of EBS were found to be 101.01% and 101.02% for wastewater and pharmaceutical formulations, respectively.

Conclusion: According to International Council for Harmonisation (ICH) guidelines, a forced degradation study of EBS was evaluated, including acid, base hydrolysis, and oxidative hydrolysis using hydrogen peroxide and photolytic and thermal degradation. The highest degradation was achieved by acid hydrolysis. The safety and efficacy of EBS were evaluated via a safety comparative profile study.