Simultaneous Estimation of Mefenamic Acid, Ethamsylate and Tranexamic Acid in Bulk and Pharmaceutical Formulations by RP-HPLC Method

A simple, new, precise, accurate and reproducible RP-HPLC method for simultaneous estimation of mefenamic acid, ethamsylate and tranexamic acid in bulk and pharmaceutical formulations. Separation of mefenamic acid, ethamsylate and tranexamic acid was successfully achieved on a Kromasil C8 (250 mm x 4.6mm x 5µ ) in an isocratic mode utilizing Ammonium acetate buffer and methanol (60:40 v/v) at a flow rate of 1.0 mL/min. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 25-75 mg/mL for mefenamic acid ,25-75 mg/mL for ethamsylate 50-150 mg/mL for tranexamic acid. The correlation coefficient was found to be 0.9997 for both the drugs. The limit of detection (LOD) was 0.158,0.2183 and 0.321 for  mefenamic acid, ethamsylate and tranexamic acid respectively. The limit of quantification (LOQ) was 0.527,0.7278 and 1.071 for mefenamic acid, ethamsylate and tranexamic acid respectively. The relative standard deviation (RSD) of six replicates is less than 2%. This HPLC method is applied successfully to the simultaneous quantitative analysis of mefenamic acid, ethamsylate and tranexamic acid in commercial tablets.