EP 8.0 monograph - impurity determination of ampicillin using a C18 HPLC column
Instrument Type: HPLC
The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of ampicillin and its impurities. The separation was performed on a Thermo Scientific Acclaim 120 C18 HPLC column using the method described in the EP 8.0 monograph. The results obtained for resolution and relative retention time (RRT) exceeded the criteria stated in the EP. Resolution between ampicillin and cefradine was 3.23 (EP criteria minimum of 3.0). RRT with reference to ampicillin and ampicillin dimer in reference solution (d) was 2.84 (EP criteria about 2.8).