Validation of the anti-factor Xa assay for the potency assessment of enoxaparin in pharmaceutical formulations.
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.
Dalmora
Sérgio Luiz
SL
Federal University of Santa Maria, Health Science Centre, Department of Industrial Pharmacy, Santa Maria-RS, Brazil. sdalmora@ccs.ufsm.br
Júnior
Liberato Brum
LB
Schmidt
Cleber Alberto
CA
Vaccari
Silvana Ferreira
SF
Oliveira
Paulo Renato
PR
Codevilla
Cristiane Franco
CF
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
D000925:Anticoagulants; D017984:Enoxaparin; D065427:Factor Xa Inhibitors; D007202:Indicators and Reagents; D012996:Solutions