The Thermo Scientific UltiMate 3000 RS HPLC System was used for the analysis of related substances of Amoxicillin . The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the EP-11.0 . The results obtained for resolution of reference solution (b) system suitability met the criteria stated in the EP-11.0. The result obtained for reference solution (b) is 6.0 (EP resolution criteria of minimum 2.0 between Amoxicillin and Cefadroxil ) for Amoxycillin-related substances as per EP 11.0 on UltiMate 3000 RS HPLC system.

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the organic impurities analysis of Cefadroxil. The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the USP 39 monograph. The results obtained for the resolution exceeded the criteria stated in the USP. The resolution between Cefadroxil related compound D and Cefadroxil related compound I was 5.3 (USP criteria of not less than 1.5).

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.

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).

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.