EP 8.0 monograph - impurity determination of cefalexin by reversed-phase HPLC-UV
Instrument Type: HPLC
The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of cefalexin and its impurities. The separation was performed on a Thermo Scientific Hypersil Gold HPLC column using the method described in the EP 8.0 monograph. The results obtained for resolution and tailing factor exceeded the criteria stated in the EP. Resolution between impurity A and B was 5.4 (EP criteria of not less than 2.0). Resolution between cefalexin and cefatoxim was 6.8 (EP criteria of not less than 1.5).