Narasapalli Narasimha Reddy¹, J Sumalatha²*, P Salomi¹ and S Nelson Kumar³

¹Department of Pharmaceutical Analysis, P. Rami Reddy Memorial College of Pharmacy, Kadapa, Andhra Pradesh, – 516003, India
²Department of Pharmaceutical Chemistry, P. Rami Reddy Memorial College of Pharmacy, Kadapa, Andhra Pradesh, – 516003, India
³Department of Pharmacology, P. Rami Reddy Memorial College of Pharmacy, Kadapa, Andhra Pradesh, – 516003, India

*Corresponding Author: J Sumalatha, Department of Pharmaceutical Chemistry, P. Rami Reddy Memorial College of Pharmacy, Kadapa, Andhra Pradesh, – 516003, India.

Received: April 24, 2025; Published: May 21, 2025

Abstract

A simple, swift, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Tranexamic acid and Ethamsylate in pharmaceutical dosage form. Chromatographic separation of Tranexamic acid and Ethamsylate was achieved on Waters Alliance-e2695 by using Zorbax SB C18 (150x 4.6mm, 3.5μ) column and the mobile phase containing Ethanol: 0.1% TFA in the ratio of 5:95% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 250nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Tranexamic acid and Ethamsylate were NLT 2000 and should not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The analytical method developed in this study underwent rigorous validation adhering to the International Council for Harmonisation guidelines to ensure its suitability for intended pharmaceutical analysis applications. The method was found to be simple, economical, suitable, precise, accurate and robust method for quantitative analysis of Tranexamic acid and Ethamsylate study of its stability.

Keywords: HPLC; Stability Indicating; Tranexamic Acid and Ethamsylatum

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Citation

Citation: J Sumalatha., et al. “Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Tranexamic Acid and Ethamsylate in Bulk and Formulation". Acta Scientific Pharmaceutical Sciences 9.5 (2025): 03-11.

Copyright

Copyright: © 2025 J Sumalatha., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.