Related substances analysis of Cefaclor using a C18 HPLC column for EP 8.0 and JP XVI monograph method
Instrument Type: HPLC
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).