USP 38 monograph - impurity determination of ceftriaxone sodium using a C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of ceftriaxone sodium and its impurities. The separation was performed on a Thermo Scientific Syncronis C18 HPLC column using the method described in the USP 38 monograph. The results obtained for resolution and signal to noise ratio exceeded the criteria stated in the USP. Resolution between ceftriaxone sodium and ceftriaxone sodium E isomer peak was 9.99 (USP criteria of not less than 3.0). Signal to noise ratio of ceftriaxone sodium peak in standard solution was 553 (USP criteria not less than 10).

EP 8.0 monograph - impurity determination of ceftriaxone sodium using a C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of ceftriaxone sodium and its impurities. The separation was performed on a Thermo Scientific Syncronis C18 HPLC column using the method described in the EP 8.0 monograph. The results obtained for resolution exceeded the criteria stated in the EP monograph. Resolution between ceftriaxone sodium and impurity A (ceftriaxone sodium E isomer) was 10.0 (EP criteria of minimum 3.0).