Related substances analysis of cefadroxyl monohydrate using a C18 HPLC column as per EP 8.0 monograph method

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the related substances analysis of cefadroxyl monohydrate. The analysis was performed on a Thermo Scientific Syncronis C18 HPLC column using the method described in the EP 8.0. The results obtained for resolution and signal-to-ratio met the criteria stated in the EP. The results obtained for resolution between the peaks due to EP Impurity A and EP Impurity B was 15.5 (EP criteria of minimum 5.0) and signal-to-ratio of EP Impurity B (0.4 µg/mL) was 56 (EP criteria of minimum 10). A sample chromatography is attached.

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).

Improved analysis of antibiotics using a Thermo Scientific Hypersil GOLD HPLC column

Instrument Type: HPLC

The Thermo Scientific HPLC system is applied for the analysis of antibiotics. The separation is performed on a Thermo Scientific Hypersil GOLD HPLC column, with UV detection at 254 nm.