Development and Validation of Reverse Phase High Pressure Liquid Chromatography for the Estimation of Mefenamic Acid in Meftal 250 Tablet

Abstract

Mefenamic acid is a Biopharmaceutical Classification System class II and a non-steroidal anti-inflammatory drug. It treats mild to severe pain, including headaches, dental pain, osteoarthritis, and rheumatoid arthritis. The aim of the present work was to develop and validate reverse phase high pressure liquid chromatography for the quantitative estimation of mefenamic acid from meftal 250. Mefenamic acid was separated on a BDS Hypersil C18 (4.6mmø×250mm) analytical column using acetonitrile: double distilled water (80:20v/v) as a mobile phase. The software used for the estimation of mefenamic acid is LAB solution software (version 6.72sp1). The retention factor of mefenamic acid was found to be 1.619 min. The linear regression analysis data for the calibration plot of drug scanned at the maximum wavelength 283nm showed a good linear relationship with r 2 = 0.9989, over the concentration range of 8 ppm to 20ppm for mefenamic acid. The validation parameters used for mefenamic acid estimation were specificity, linearity, precision, accuracy, robustness, and sensitivity (limit of detection and limit of quantification). The approach was discovered to be precise, accurate, sensitive, and robust, satisfying all of the requirements specified by the International Council for Harmonisation guideline Q2 (R1). Thus, the developed high pressure liquid chromatography method can conveniently be employed for the detection and quantification of mefenamic acid in commercial formulation.