Objective To establish a GC Method for the determination of residual organic solvents in Pitavastatin Calcium. Method A simple capillary column injection method used for the determination of residual methanol, ethanol, dichlormethane, N-hexane and tetrahydrofuran, in Pitavastatin Calcium. Results The linearities were good, the average recoveries were 100.0% ~102.2%, and RSD0.6%~ 1.0%, the detection limits were 0.1~0.5μg/mL. Conclusion This method is fast and accurate, and is suitable to the material quality contro1. |