Spectrophotometric Methods for Determination of Tranexamic Acid and Etamsylate in Pure Form and Pharmaceutical Formulation

Abstract

Background: Tranexamic acid and etamsylate drugs belong to a group of antifibrinolytics. Tranexamic Acid (TRA) is the most potent antifibrinolytic lysine analogue used in a broad spectrum of peri-and postoperative interventions and bleeding disorders. The administration of TRA is associated with a reduction in bleeding due to its inhibitory effect on clot breakdown (fibrinolysis). Etamsylate (ESL) is a haemostatic agent that appears to maintain the stability of the capillary wall and correct abnormal platelet adhesion. It is given for the prophylaxis and control of haemorrhages from small blood vessels. Objective: Two simple and sensitive spectrophotometric methods are described for the determination of tranexamic acid (TRA) and etamsylate (ESL) drugs in pure form and pharmaceutical preparations. Materials and Methods Method (A) is used for the determination of TRA and based on condensation reaction of the primary amino group of TRA with salicylaldehyde reagent (SA) (Schiff base formation) producing a yellow coloured product which is measured spectrophotometrically at 400 nm. Method (B) is utilized for the determination of ESL and based on the oxidation-reduction reaction of ESL using iodic acid (HIO3). The liberated iodine was extracted in chloroform and the absorbance of the red coloured product is measured spectrophotometrically at 510 nm. For method A and B, different variables affecting the reactions were studied and optimized. Results: Under the optimum conditions, linear relationships with good correlation coefficients 0.9989 and 0.9959 were found between the absorbance and the concentration of the drug in the range from 5 to 500 and 2.5 to 275 μg mLG1 for ESL and TRA drugs, respectively. The limit of detection (μg mLG1), limit of quantification (μg mLG1) and molar absorptivity (L molG1 cmG1) values were found to be 1.442, 4.80 and 5.39×102 for TRA drug and 2.20, 7.25 and 3.0×102 for ESL drug, respectively. Conclusion: The method was applied for determination of the investigated drugs in tablets. The method was validated and can be suggested for routine analysis of both drugs.