International Journal of Drug Delivery Technology
Volume 14, Issue 1

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

Rakesh Shivatare1*, Shailesh Kewatkar2, Neetin Bhutale1, Vibhavari Chatur3, Harshal Tare4

1Department of Pharmaceutical Sciences, JJT University, Jhunjhunu, Rajasthan, India

2Department of Pharmacognosy Rajarshi Shahu College of Pharmacy, Buldana, Maharashtra, India.

3Department of Pharmaceutical Sciences, PES Modern College of Pharmacy, Moshi, Pune, Maharashtra, India.

4Dr. Harshal Tare (OPC) Pvt. Ltd., Jalgaon, Maharashtra, India

Received: 16th November, 2023; Revised: 10th December, 2023; Accepted: 04th January, 2024; Available Online: 25th March, 2024

ABSTRACT

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.

Keywords: Ximenynic acid, Santalum album L, IVRT, HPLC

International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.1.44

How to cite this article: Shivatare R, Kewatkar S, Bhutale N, Chatur V, Tare H. A Validated IVRT Method to Evaluate Semisolid Dosage Form Containing Ximenynic Acid Using a Novel Approach. International Journal of Drug Delivery Technology. 2024;14(1):306-315.

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