Simultaneously Determination of Residual Organic Solvents in Rivaroxaban Drug Substance by GC

OBJECTIVE To establish a capillary GC method for the determination of residual organic solvents including alcohol, dichloromethane, tetrahydrofuran, triethylamine, pyridine, acetic acid, N, N-dimethylformamide (DMF) in rivaroxaban drug substance. METHODS This method utilized an Agilent DB-624 column(30 m×0.32 mm, 1.8 mm), N2 as carrier gas. FID was used as detector with the temperature of 240 ℃, and the inlet temperature was 200 ℃. This method used temperature program and the flow rate was 2.0 mL·min^-1. The injection volume was 1 μL. RESULTS The 7 residual organic solvents alcohol, dichloromethane, tetrahydrofuran, trimethylamine, pyridine, acetic acid, DMF were completely separated, the linear relationship was good, and the average recoveries were 102.4%, 100.1%, 96.5%, 91.6%, 103.6%, 106.6%, 102.5%, respectively, and the RSD were all <5.0%. CONCLUSION This method is simple, rapid, accurate and highly sensitive, which can be used for the determination of the residual organic solvents in rivaroxaban drug substance.