Physical and chemical characterization of mefenamic acid in different pharmaceutical dosage forms and their stability studies using novel RP-HPLC method

Abstract

A novel RP-HPLC method for the determination of mefenamic acid in raw material, different pharmaceutical forms, and in human serum for routine analysis, therapeutic purposes, and stability studies was developed and validated. This study is also a collection of studies performed on the physical and chemical aspects of mefenamic acid. The method developed constitutes mobile phase, acetonitrile:acetic acid:water (72.5:1:26.5, v/v/v) at pH 3 and mefenamic acid was monitored with UV detection at 279 nm, eluting out at 3.98 min. The present HPLC method was found to be linear (100–300 μg mL−1), accurate, and least time consuming with very good recovery. The limits of detection of the method were found to be 10 μg mL−1. This method was also used to study the stability profile of mefenamic acid in tablets for 5 years and suspension for 4 years. The excipients present in the formulation did not interfere with the assay. The present method was also compared with the UV–visible technique and it was observed that HPLC method is more precise, sensitive, and accurate.