EP 8.0 monograph - impurities test for piracetam using a C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of piracetam and its impurities. The separation was performed on a Thermo Scientific Syncronis C18 HPLC column using the method described in the USP monograph. The results obtained for resolution and asymmetry exceeded the criteria stated in the USP. Resolution between piracetam and impurity A was 4.8 (USP criteria of not less than 3.0). Asymmetry of piracetam was 1.2 (USP criteria of not more than 2.0).