A Validated IVRT Method to Evaluate Semisolid Dosage Form Containing Ximenynic Acid Using a Novel Approach

Purpose: Ximenynic acid (XMA) holds significant potential in the market, especially due to its widespread application in the cosmetics sector. As its various biological activities continue to be discovered, there is a sharp rise in demand for ximenynic acid. A novel analytical approach has been devised for an in-house product, comparable to the reference listed drug (Softalia, containing 30% ximenynic acid), utilized in gel formulations. This method is designed to conduct in-vitro release studies employing Franz vertical diffusion cell apparatus and analytical quantification via high-performance liquid chromatography (HPLC). Methods: The methodology has been assessed concerning specificity, linearity, the limit of quantitation (LoQ), limit of detection (LoD), inter-day precision, intermediate precision, accuracy, and solution stability. Following method development, the reference product containing 30% ximenynic acid underwent testing against the in-house XMA semisolid dosage form to accurately demonstrate “equivalence”, with results aligning with the applicable acceptance criteria falling within the range of 75 to 133.33%, as outlined in the FDA’s SUPAC-SS guidance. The in-vitro release assay has proven valuable for quality assurance, batch comparison, and monitoring the impacts of different formulations, scales, scaling up/down, methods, locations, and other variables. Results: This research fabricates specific IVRT techniques for performing assessments of semisolid dosage forms, which are required for many regulatory purposes.