J AOAC Int. 2004 Nov-Dec;87(6):1305-8.

Validation of the anti-factor Xa assay for the potency assessment of enoxaparin in pharmaceutical formulations.

Dalmora SL, Júnior LB, Schmidt CA, Vaccari SF, Oliveira PR, Codevilla CF.

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Federal University of Santa Maria, Health Science Centre, Department of Industrial Pharmacy, Santa Maria-RS, Brazil. sdalmora@ccs.ufsm.br

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.

PMID:: 15675440; [PubMed - indexed for MEDLINE]

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Validation of the anti-factor Xa assay for the potency assessment of enoxaparin in pharmaceutical formulations.

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