Kuni Vijaypal¹, 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, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Aspirin and Rivaroxaban in pharmaceutical dosage form. Chromatographic separation of Aspirin and Rivaroxaban was achieved on Waters Alliance-e2695by using Waters Zorbax SB C18 (150x 4.6mm, 3.5μ) column and the mobile phase containing Acetonitrile: Ammonium Formate pH-3.0/OPA in the ratio of 50:50% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 269nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Aspirin and Rivaroxaban 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 proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate and robust method for quantitative analysis of Aspirin and Rivaroxaban study of its stability.

Keywords: HPLC; Validation; Aspirin and Rivaroxaban

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Citation

Citation: J Sumalatha., et al. RP-HPLC Method Development and Validation for Simultaneous Estimation of Aspirin and Rivaroxaban in Bulk and Formulation". Acta Scientific Pharmaceutical Sciences 9.5 (2025): 12-19.

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.