Analytical Method Development and Method Validation of Enoxaparin Sodium Using Uv-Visible Spectrophotometer

Abstract

Enoxaparin Sodium is a well-known low molecular weight heparin that is used for the prevention and management of various thromboembolic disorders. This study was conducted with an objective of developing a rapid, accurate, and economical UV-Visible spectrophotometric method for quantification of Enoxaparin Sodium in formulation aligning with principles of affordable healthcare and sustainable manufacturing by minimizing solvent use and analytical costs. Spectral analysis was performed using 0.1 M Hydrochloric Acid as solvent, with λmax of 232 nm.
It was observed that the method had good linear relationship within the concentration range from 5 µg/mL to 25 µg/mL with a correlation coefficient value of 0.9980. Validation of the test was done in accordance with the guidelines of ICH Q2 (R1).The precision of the method was confirmed by low %RSD values for both intraday (0.4750%) and interday studies (<0.5%). The method demonstrated good repeatability with %RSD of 0.4663%. Accuracy studies showed satisfactory recovery in the range of 99–102%, indicating the reliability of the method thereby supporting quality assurance in pharmaceutical supply chains.
It was discovered that the limits of detection (LOD) and quantitation (LOQ) were 0.1542 µg/mL and 0.4642 µg/mL, respectively, indicating sufficient sensitivity. Robustness testing showed that small variations in wavelength (±2 nm) did not significantly affect the results, with % deviation less than 2%.his cost-effective and eco-friendly approach contributes to responsible consumption and supports innovation in analytical infrastructure for resource-limited settings.