Determination of mangafodipir trisodium and related impurities in bulk substance and pharmaceutical formulation by ion-pair high-performance liquid chromatography.
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.
Gjerde
H
H
Analytical Sciences R&D, Nycomed Imaging AS, P. O. Box 4220 Nydalen, 0401, Oslo, Norway. hgj@nyocomed.com
Snøtun
A
A
Hem
H
H
Larsen
K H
KH
Døhl
J
J
D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003287:Contrast Media / Q000032:analysis*; D004492:Edetic Acid / Q000031:analogs & derivatives* / Q000032:analysis*; D011732:Pyridoxal Phosphate / Q000031:analogs & derivatives* / Q000032:analysis*; D011786:Quality Control; D012015:Reference Standards
D003287:Contrast Media; D011732:Pyridoxal Phosphate; D004492:Edetic Acid; C060076:N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid