Abstract

Determination of Assay and Chromatographic Purity of Fondaparinux Sodium by Sax HPLC

Author(s): G. Kavitha, G. Nadamuni, K. Mukkanti and V. N. S. M. V. G. Raju

A new, simple, sensitive and accurate SAX HPLC method was developed for determination of Fondaparinux sodium in Fondaparinux sodium injection. This method can be used for determination of assay and chromatographic purity of Fondaparinux sodium in Arixtra and other injectable formulations containing Fondaparinux sodium. Chromatographic separation was achieved using a high quality polystyrene-divinyl benzene resin based SAX column (with covalent bonded trimethylammonium anion exchange groups); a linear gradient elution from 10% to 41% of solution-B, which is 0.5 M lithium perchlorate containing 5 mM disodium hydrogen phosphate at pH 6.8 and solution-A being 5 mM disodium hydrogen phosphate at pH 2.5 and a UV detection at 210 nm was employed. The method has been validated and was found to be precise and accurate for determination of both assay and chromatographic purity of Fondaparinux sodium in Arixtra injection. The limit of detection for Fondaparinux was found to be 3.3 μg/mL, which is 0.06% with respect to the method concentration of 5.0 mg/mL. The method was found to be linear over the range of 50-150% of the method concentration. The precision, accuracy, specificity, robustness and solution stability were determined.