PHARMACEUTICAL ANALYSIS OF THE ORAL IRON CHELATOR DEFERIPRONE (DMHP,L1)

The oral iron chelator deferiprone (1,2-dimethyl-3-hydroxy-pyrid-4-one , DMPH, L1 or CP20) can be useful drug in patients with transfusional hemosiderosis. From 1987 about 1000 patients in 16 countries have take n this drug on the base of clinical trials or compassionate use. Since this compound is only available as a raw substance, it is important t o ascertain its purity before bringing the drug into a pharmaceutical formulation. Because deferiprone is administered chronically and in hi gh doses, intake of potential toxic impurities can be substantial. In this article a proposal for the quality control of deferiprone is pres ented in the form of a pharmaceutical monograph. This includes the ana lytical methods required for identification, purity checking and assay . Furthermore the way we synthesized the drug to get hold of it in a p ure form is described. This synthesis is also used in manufacturing th e drug commercially. The monograph can be used as a guideline for stan dardization of the quality of deferiprone to be used for further study treatment.