Validation of the anti-factor IIa assay and potency assessment of enoxaparin in pharmaceutical formulations.
The low molecular weight heparin enoxaparin sodium is used clinically for the prevention and treatment of venous and arterial thrombosis. An anti-factor IIa assay was applied and validated for the potency evaluation of the pharmaceutical formulations. Investigating the parameters of range, linearity (r(2)=0.9912), precision, accuracy and robustness, the biological assay incorporated a chromogenic end-point and detection at 405 nm. The method yielded good results with a detection limit of 0.01 IU/ml and a quantitation limit of 0.03 IU/ml. Sodium enoxaparin pharmaceutical products were evaluated by the anti-factor Xa assay and the anti-factor IIa assay giving potencies between 97.18% and 106.50%, with an anti-factor Xa/anti-factor IIa ratio between 3.9 and 4.2. The results demonstrated the validity of the anti-factor IIa assay that together with the anti-factor Xa are useful methodologies for the routine quality control of enoxaparin in pharmaceutical products.
Dalmora
Sérgio Luiz
SL
Department of Industrial Pharmacy, Health Science Centre, Federal University of Santa Maria, 97.1105-900-Santa Maria-RS, Brazil. sdalmora@ccs.ufsm.br <sdalmora@ccs.ufsm.br>
Junior
Liberato Brum
LB
Vaccari
Silvana Ferreira
SF
Fronza
Marcio
M
Renato de Oliveira
Paulo
P
Rolim
Clarice Madalena Bueno
CM
D000925:Anticoagulants / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D017984:Enoxaparin / Q000032:analysis* / Q000494:pharmacology; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use; D011516:Prothrombin / Q000037:antagonists & inhibitors*; D015203:Reproducibility of Results; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control
D000925:Anticoagulants; D017984:Enoxaparin; D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight; D011516:Prothrombin; C025337:Factor IIa