EP 8.0 monograph: impurity determination of amoxicillin using a C18 HPLC column
Instrument Type: HPLC
The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of amoxicillin 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 relative retention time (RRT) exceeded the criteria stated in the EP. Resolution between amoxicillin and cefadroxil was 10.0 (EP criteria of not less than 2.0). RRT of impurity C and impurity J with respect to amoxicillin was 3.2 and 3.8 respectively (EP criteria of impurity C 3.4 and impurity J 4.1).