Yang Xiaorong, Zou Hanyan, Dong Yixue, Liu Bing, Wang Ying, Wang Mengying
Chongqing Institute for Food and Drug Control, Chongqing, China.
PeerJ. 2024 Dec 18;12:e18732. doi: 10.7717/peerj.18732. eCollection 2024.
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.
依诺肝素钠是有效抗凝治疗所必需的低分子质量肝素。然而，不同制造商的检测方法存在显著差异，导致结果的重现性较差，增加了制造商进行药物质量评估和监管监督的风险。本研究整合了各种检测方法的优势，建立了一种经过充分验证的可重现检测方法。验证结果表明，该方法具有优异的特异性、线性、稳健性、精密度和准确度，回收率在98.0%至102.0%之间。新方法具有高度的一致性和重现性，相对标准偏差（RSD）值小于2.0%，并且通过减少试剂用量、实验成本和设备要求，显示出取代欧洲药典方法的潜力。该方法的可靠结果便于在不同实验室采用，加强依诺肝素钠的质量控制，并为新制造商和药品监管当局提供参考，从而确保用药安全。
