Design, development and validation of an RP-HPLC method for concurrent estimation of tranexamic acid and ethamsylate in bulk and pharmaceutical formulations

A reversed-phase high-performance liquid chromatography method is developed and validated for the determination of tranexamic acid Ethamsylate in bulk drug and marketed dosage forms. The chromatographic determination was performed on Shimadzu Lab solutions with a variable wavelength detector. The separation was conducted using thermoscientific Hypersil BDS (150 mm x 5 mm) with a mobile phase consisting of phosphate buffer: acetonitrile (80:20, %v/v) ratio. The mobile phase was delivered at a flow rate of 1.0 mL/min. The eluents were monitored at wavelength 280 nm and found sharp and symmetrical peaks with retention times of 3.27 and 4.27 min. The method was validated for linearity, accuracy, precision, and system suitability. The method was found to be linear over the concentration range 10-30µg/mL, 10-30µg/ml, with regression 0.999. The percentage recoveries for Tranexamic acid and Ethamsylate were found to be in the range of 100.41% and100.31 %, respectively. The developed HPLC technique is precise, specific, accurate, and stable. Hence, this study proves that the method is reproducible, selective, and suitable to be applied for the analysis of tranexamic acid Ethamsylate in commercial pharmaceutical dosage form for quality control applications.