USP 38 monograph: impurity determination of metronidazole using a C8 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of Metronidazole and its impurities. The separation was performed on a Thermo Scientific Acclaim 120 C8 HPLC column using the method described in the USP 38 monograph. The results obtained for resolution and tailing factor exceeded the criteria stated in the USP. Resolution between tinidazole compound A and metronidazole was 8.1 (USP criteria of not less than 2.0) and tailing factor for metronidazole was 1.0 (USP criteria not more than 2.0).