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Determination of mangafodipir trisodium and related impurities in bulk substance and pharmaceutical formulation by
1Analytical Sciences R&D, Nycomed Imaging AS, P. O. Box 4220 Nydalen, 0401, Oslo, Norway. hgj@nyocomed.com
Abstract:
The development of an ion-pair liquid chromatographic method for determination of mangafodipir trisodium and related impurities is described. Good resolution was obtained when using a polymeric reverse-phase column and a mobile phase of pH* 10.5 composed by borate buffer, acetonitrile, and tetrabutylammonium hydrogensulphate as ion pair agent. Validation of the method showed good selectivity, precision, accuracy and linearity, and detection limits of 0.1--0.2 microg/ml.
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