Assay and related substances analysis of cefepime hydrochloride using a C18 HPLC column as per USP 39 monograph

Instrument Type: HPLC

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).