Analysis of Tolfenamic Acid using a Simple, Rapid, and Stability-indicating Validated HPLC Method.

This study focuses on analysis of tolfenamic acid using a simple, rapid, and stability-indicating validated hplc method.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the pharmaceutical field. Tolfenamic acid (TA) belongs to the fenamates class of nonsteroidal anti-inflammatory drugs. Insufficient information is available regarding the availability of a reliable and validated stability-indicating method for the assay of TA.... Research Background and Significance Tolfenamic acid (TA) is a nonsteroidal anti-inflammatory drug (NSAID) belonging to the fenamates class, widely used for its anti-inflammatory and analgesic properties. Despite its clinical importance, the literature reveals a scarcity of reliable, validated, and stability-indicating high-performance liquid chromatography (HPLC) methods for its quantitative analysis in pharmaceutical formulations. Stability-indicating methods are critical in pharmaceutical quality control to ensure the drug’s potency and safety throughout its shelf life by detecting degradation products. This study addresses this gap by developing a simple, rapid, and validated HPLC method specifically designed to analyze tolfenamic acid. The significance lies in providing a dependable analytical tool that can streamline quality control processes, reduce analysis time, and ensure compliance with regulatory standards for pharmaceutical products containing TA. Experimental Design and Methodology The study utilized reversed-phase HPLC techniques due to their widespread applicability in pharmaceutical analysis for nonpolar to moderately polar compounds like tolfenamic acid. The experimental design focused on developing a method that is not only rapid but also stability-indicating,