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

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

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

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

PubMed ID

15675440 [ View in PubMed

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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.

DrugBank Data that Cites this Article

Drug Targets

Drug	Target	Kind	Organism	Pharmacological Action	Actions
Enoxaparin	Coagulation factor X	Protein	Humans	Yes	Inhibitor	Details