USP 38 monograph: assay analysis of penicillin G sodium using an aQ HPLC column

Instrument Type: HPLC

The analysis was performed on a Thermo Scientific Dionex UltiMate 3000 HPLC system and a Thermo Scientific Syncronis aQ HPLC column. All USP criteria was exceeded. Resolution between 2-phenylacetamide and penicillin G potassium was 6.1 (USP criteria of not less than 2.0). Tailing factor for penicillin G potassium was 1.5 (USP criteria not more than 2.0). The % RSD for replicate injections of standard solution was 0.2% (USP criteria not more than 2.0%). The relative retention time of 2 phenylacetamide peak with respect to penicillin G potassium peak was 0.7 (USP criteria about 0.8).