USP 38 monography - assay of lovastatin related compound A using a C8 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay analysis of lovastatin related compound-A. The analysis was performed on a Thermo Scientific Syncronis C8 HPLC column using the method described in the USP 38 monograph. Resolution between lovastatin and lovastatin related compound A was 10.9 (exceeded USP criteria of NLT 6.0). Relative retention time of lovastatin related compound A with respect to lovastatin was 1.39 (met USP criteria of about 1.3). The % RSD for replicate injection of standard solution was 0.9% (exceed USP criteria not more than 5.0%).