DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF TRANEXAMIC ACID AND ETHAMSYLATE IN BULK AND TABLET DOSAGE FORM

The present study demonstrates the method development and validation for simultaneous estimation of Ethamsylate & Tranexamic acid in combined pharmaceutical dosage form by using RP-HPLC along with the stability studies. According to ICH guidelines for stability testing of new drug substances and products, both the drugs were subjected to various stress conditions. The chromatographic separation was carried out on ALLIANCE C18 column with the dimensions of 250 mm x 4.6 mm x 5µm using Waters 2695 HPLC instrument equipped with 2998 series of PDA detector. The isocratic mobile phase used was made up of Phosphate Buffer with pH adjusted at 3.1 & Acetonitrile (ACN) in the ratio 80:20 v/v with the flow rate of 1.0 ml /min and both the drugs have been detected using UV detector at 250 nm. At room temperature Ethamsylate and Tranexamic acid were found to have retention times of 2.522 & 4.739 minutes respectively with a total run time of 7 minutes. The developed method was validated by utilizing various validation parameters and the force degradation & stability studies were applied to analyse the stability and to identify settlement of the degradation products. The established method can be applied for the simultaneous determination of ETS & TXA in combined dosage form.

Keywords: ETS (Ethamsylate), TXA (Tranexamic acid) ACN(Acetonitrile).