EP 8.0 monograph - impurity determination of betamethasone using a C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 HPLC system is applied for the analysis of Betamethasone and its impurities. The separation was performed on a Thermo Scientific Syncronis C18 column using the method described in the EP 8.0 monograph. The results obtained for resolution between methylprednisolone and betamethasone was 1.55. This exceeds the EP criteria of minimum of 1.5 and the resolution can be further increased by optimising the acetonitrile concentration in mobile phase A in accordance with criteria in the monograph.