The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the related substances analysis of cefepime dihydrochloride hydrate. The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the JP XVI and KP X. The results obtained for theoretical plates and %RSD for cefepime met the criteria stated in the JP/KP monograph. The results obtained for theoretical plates of cefepime was 54,132 (JP/KP criteria of not less than 6,000) and %RSD for cefepime was 0.1% (JP/KP criteria of not more than 2).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the related substances analysis for Cefazolin as per EP. The analysis was performed on a Thermo Scientific Hypersil Gold HPLC column using the method described in the EP 8.1 Monograph. The results obtained for resolution met the criteria as per EP. The results obtained for the resolution between Cefazolin & impurity L is found to be 5.3 (EP criteria is NLT 2.0).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of assay and organic impurities for Cefixime as per the USP 39 monograph. The analysis was performed on a Thermo Scientific Syncronis C18 HPLC column using the method described in the USP 39 monograph. The results obtained for resolution met the criteria as per USP. The results obtained for the resolution between Cefixime & Cefixime (E)-isomer was 2.32 (USP criteria is NLT 2.0). Column efficiency was found to be >4500 (USP criteria - NLT 4000 theoretical plates).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay and related substances analysis of cefepime hydrochloride. The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the USP 39. The results obtained for resolution and tailing factor met the criteria stated in the USP. The results obtained for resolution between the peaks due to cefepime related compound D and cefepime related compound E was 3.7 (USP criteria of NLT 2.0) and tailing factor for cefepime was 1.3(USP criteria of NMT 1.5).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the related substances analysis of cefaclor. The analysis was performed on a Thermo Scientific Syncronis C18 HPLC column using the method described in the EP 8.0 and JP XVI. The results obtained for resolution and theoretical plates met the criteria stated in the EP/JP. The results obtained for resolution between the peaks due to cefaclor and EP Impurity D was 11.1 (EP criteria of minimum 2.0) and theoretical plates for cefaclor was 1,12,359 (JP criteria of minimum 40,000).