Abstract
Enoxaparin sodium is a low molecular mass heparin essential for effective anticoagulation therapy. However, significant variations in testing methods across different manufacturers have led to poor reproducibility of results, increasing the risks associated with drug quality evaluation by manufacturers and regulatory oversight. This study integrates the strengths of various testing methods to establish a reproducible assay that has been thoroughly validated. The validation results demonstrate that the method exhibits excellent specificity, linearity, robustness, precision, and accuracy, with recovery rates ranging from 98.0% to 102.0%. The new method demonstrated high consistency and reproducibility, with an RSD value of less than 2.0%, and showed the potential to replace the European Pharmacopoeia method by reducing reagent usage, experimental costs, and equipment requirements. The reliable results of this method facilitate its adoption across different laboratories, enhance the quality control of enoxaparin sodium, and provide a reference for new manufacturers and drug regulatory authorities, thereby ensuring medication safety.
Published Version
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
