Methods for analysis and resolution of preparations of dianhydrogalactitol and derivatives or analogs thereof
AssigneeDel Mar Pharmaceuticals (BC) Ltd.
InventorQiang Xu
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Abstract
An improved analytical method for analysis of dianhydrogalactitol preparations provides a method for determining the purity of dianhydrogalactitol and detecting impurities in preparations of dianhydrogalactitol, as well as identifying any such impurities. The method employs high performance liquid chromatography (HPLC), in particular, HPLC employing a reverse phase amide column with ELSD detection; the HPLC can be followed by tandem mass spectroscopy. The method can further comprise the step of performing preparative HPLC collection of at least one specific substance peak present in a preparation of dianhydrogalactitol.
Claims20
An analytical method for analyzing the presence and quantity of impurities present in a preparation of dianhydrogalactitol comprising the steps of:
- (a) analyzing a preparation of dianhydrogalactitol by subjecting the preparation to high performance liquid chromatography using a reversed phase amide column employing amide chemistry in a hydrophilic interaction mode and ethylene bridged hybrid (BEH) technology with elution with a mobile phase gradient wherein a first mobile phase is 100% acetonitrile and a second mobile phase is 100% water to separate dianhydrogalactitol from dulcitol and other contaminants of the preparation;
- and
- (b) determining the relative concentration of one or more peaks resolved by high performance liquid chromatography that represent compounds other than dianhydrogalactitol itself.
Dependencies are inferred from the claim text.