HPLC-UV-CAD method was established in this paper and the consistency of the generic drug for cefepime of injection was evaluated from the impurity profile and excipients. On the basis of UV detection and the charged aerosol detection (CAD) combined with a mixed matrix column Trinity-P1. By adjusting the organic phase and salt concentration, a method for determining the arginine of the auxiliary material was established. The determination can be made simultaneously with the main component of the drug and the salt forming ion.

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 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).

This work describes the determination of N-Methylpyrrolidine by cation-exchange chromatography with non-suppressed conductivity detection. This method is different from the one described in AN199, which uses suppressed conductivity. The results shown here meet the USP criteria for Organic Impurities, Procedure 1 (Limit of N-Methylpyrrolidine) in the proposed methods for cefepime hydrochloride and Cefepime for Injection.

This application note describes a cation-exchange chromatography method that significantly reduces the time between injections relative to the current USP method (by approximately 3 h) due to the very low hydrophobic character of the IonPac® CS17 column, enabling a faster elution of strongly retained compounds (e.g., cefepime). The linearity, detection limits, precision, and recovery of NMP in cefepime hydrochloride are determined. The limit of quantitation for this method is approximately 0.001% NMP, well within the limit of 0.3% set in the USP method.