title: Validation of the anti-factor Xa assay for the potency assessment of enoxaparin in pharmaceutical formulations.
abstract: 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.
authors.affiliation: Federal University of Santa Maria, Health Science Centre, Department of Industrial Pharmacy, Santa Maria-RS, Brazil. sdalmora@ccs.ufsm.br
authors.forename: Sérgio Luiz
authors.initials: SL
authors.lastname: Dalmora
authors.forename: Liberato Brum
authors.initials: LB
authors.lastname: Júnior
authors.forename: Cleber Alberto
authors.initials: CA
authors.lastname: Schmidt
authors.forename: Silvana Ferreira
authors.initials: SF
authors.lastname: Vaccari
authors.forename: Paulo Renato
authors.initials: PR
authors.lastname: Oliveira
authors.forename: Cristiane Franco
authors.initials: CF
authors.lastname: Codevilla
mesh_terms: D000925:Anticoagulants / Q000032:analysis* / Q000494:pharmacology; D001681:Biological Assay; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D017984:Enoxaparin / Q000032:analysis* / Q000494:pharmacology; D065427:Factor Xa Inhibitors; D006801:Humans; D007202:Indicators and Reagents; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D065427:Factor Xa Inhibitors; D007202:Indicators and Reagents; D012996:Solutions