Establishment and validation of a method for determining anti-Xa factor potency of enoxaparin sodium
En Zhang, Hanyan Zou, Yandong Dong, Bing Liu, Xiaorong Yang
TL;DR
The paper introduces a new, efficient method to measure the potency of enoxaparin sodium, a drug used to prevent blood clots, which is reliable and cost-effective.
Contribution
A novel validated method for determining anti-Xa factor potency of enoxapoein sodium with high efficiency and low cost.
Findings
The method showed a linear detection range of 0.054–0.192 IU/mL with strong correlation.
Precision, robustness, and accuracy were within 2.0% RSD, meeting pharmacopoeia standards.
The method reduces sample and reagent use, lowers costs, and streamlines procedures compared to traditional methods.
Abstract
This study successfully established and validated an efficient, reliable, and user-friendly method for determining the anti-Xa factor potency of enoxaparin sodium. Comprehensive validation experiments demonstrated the method’s excellent performance in terms of specificity, linearity, precision, accuracy, and robustness. The method exhibited a linear detection range of 0.054–0.192 IU/mL with a strong correlation coefficient, and its precision, robustness, and consistency with the European Pharmacopoeia method were all within 2.0% relative standard deviation (RSD). These results indicate high reproducibility and strong applicability, making the method suitable for seamless transfer between laboratories. Accuracy experiments revealed recovery rates ranging from 98.0% to 102.0%, confirming the reliability of the results. The validation design and performance of this method comply with the…
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Taxonomy
TopicsPesticide Residue Analysis and Safety · Analytical Methods in Pharmaceuticals · Cardiac electrophysiology and arrhythmias