Determination of Sodium in Enoxaparin Sodium (Heparin) by Atomic Absorption Spectrometry

Abstract

Enoxaparin sodium is the salt of a low-molecular-mass heparin that is used to treat thrombotic disorders. Initially approved by the FDA in 1993, it is administered by a subcutaneous or intravenous injection and marketed by the several pharmaceutical companies. The U.S. Pharmacopeia (USP) and U.S. Food and Drug Administration (FDA) have worked extensively to modernize the unfractionated heparin and enoxaparin monographs. This paper reports the development of the determination of Na in Enoxaparin Sodium (Heparin) by flame atomic absorption spectrophotometry. The method is convenient, and the results show good precision and accuracy. The sodium amount has been found 5.09 ppm (mg/Kg). Correlation coefficient (R²) of 0.9978.  The relative standard difference (%RPD) is 1.55% and the rate of recovery is 100.8%. The results show that the concentration of Na meets the USP specifications.