Validation of the anti-factor Xa assay for the potency assessment of enoxaparin in pharmaceutical formulations |
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Authors: | Dalmora Sérgio Luiz Júnior Liberato Brum Schmidt Cleber Alberto Vaccari Silvana Ferreira Oliveira Paulo Renato Codevilla Cristiane Franco |
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Affiliation: | Federal University of Santa Maria, Health Science Centre, Department of Industrial Pharmacy, Santa Maria-RS, Brazil. sdalmora@ccs.ufsm.br |
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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. |
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