Validation of the anti-factor Xa assay for the potency assessment of enoxaparin in pharmaceutical formulations

• Published in: Journal of AOAC International Vol. 87; no. 6; pp. 1305 - 1308
• Main Authors: LUIZ DALMORA, Sérgio, BRUM JUNIOR, Liberato, SCHMIDT, Cleber Alberto, FERREIRA VACCARI, Silvana, RENATO OLIVEIRA, Paulo, FRANCO CODEVILLA, Cristiane
• Format: Journal Article
• Language: English
• Published: Gaithersburg, MD AOAC International 01-11-2004
• Subjects: Anticoagulants - analysis; Anticoagulants - pharmacology; Biological and medical sciences; Biological Assay; Calibration; Chemistry, Pharmaceutical; Enoxaparin - analysis; Enoxaparin - pharmacology; Factor Xa Inhibitors; General pharmacology; Humans; Indicators and Reagents; Medical sciences; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Reference Standards; Reproducibility of Results; Solutions; Validation; Pharmaceutical technology; Serine endopeptidases; Enzyme; Coagulation Factor Xa; Anticoagulant; Enoxaparin sodium; Assay; Peptidases; Formulation; Dosage form; Hydrolases; Heparin
• ISSN: 1060-3271; 1944-7922
• DOI: 10.1093/jaoac/87.6.1305

Enoxaparin is a low-molecular weight heparin used clinically for the prevention and treatment of venous and arterial thrombosis. An anti-factor Xa assay was used to evaluate the potency of the final drug preparation. Method validation investigated parameters such as the range, linearity (r2 = 0.9971), precision, accuracy, and robustness; the biological assay incorporated a chromogenic endpoint and detection at 405 nm. The method yielded good results with a quantitation limit of 0.037 IU/mL and a detection limit of 0.011 IU/mL. The results demonstrated the validity of the anti-factor Xa assay for the determination of enoxaparin.