RESUMO
The low-molecular weight heparin nadroparin calcium is used clinically for the prevention and treatment of venous and arterial thrombosis. The antifactor Xa and antifactor IIa assays were validated by investigating the parameters of range, linearity (r2 = 0.9905 and r2 = 0.9914, respectively) precision, accuracy, and robustness. The 2 methods incorporated a chromogenic endpoint and detection at 405 nm, yielding good results with detection limits of 0.004 and 0.01 IU/mL and quantitation limits of 0.01 and 0.03 IU/mL, respectively, for the antifactor Xa and antifactor IIa assays. Nadroparin calcium pharmaceutical products were evaluated by the antifactor Xa assay and the antifactor IIa assay, giving potencies between 93.86 and 109.88%, with an antifactor Xa/antifactor IIa ratio between 3.2 and 3.7. The results demonstrated the validity of the assays that are useful methodologies for the routine quality control of nadroparin in pharmaceutical formulations.
Assuntos
Técnicas de Química Analítica/métodos , Química Farmacêutica/métodos , Fator Xa/análise , Nadroparina/análise , Protrombina/análise , Animais , Calibragem , Bovinos , Fator Xa/química , Humanos , Nadroparina/química , Protrombina/química , Controle de Qualidade , Reprodutibilidade dos Testes , Trombose/prevenção & controle , Fatores de Tempo , Trombose Venosa/prevenção & controleRESUMO
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.
Assuntos
Química Farmacêutica/métodos , Enoxaparina/análise , Protrombina/antagonistas & inibidores , Anticoagulantes/uso terapêutico , Enoxaparina/farmacologia , Fibrinolíticos/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Reprodutibilidade dos Testes , Trombose/etiologia , Trombose/prevenção & controleRESUMO
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.
