To provide an application for the analysis of statins using the Thermo Scientific™ Hypersil GOLD VANQUISH™ 1.9 µm column and Thermo Scientific™ Vanquish H™ UHPLC system, exploiting the non-linear gradient capability of the systemDemonstrate the opportunity for increased throughput by operating at higher flow rates and backpressures
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%).
