Determination of Residual Organic Solvents in Sevelamer Hydrochloride Drug Substance by GC

OBJECTIVE To establish a capillary GC method for the determination of residual organic solvents including alcohol, isopropanol, epichlorohydrin (ECH) in sevelamer hydrochloride drug substance. METHODS This method utilized an Agilent DB-624 GC column, helium as carrier gas. FID was used as detector with the temperature of 220 ℃, and the inlet temperature was 180 ℃. This method used temperature program. The injection volume was 1 μL. RESULTS The three residual organic solvents alcohol, isopropanol, ECH were completely separated, the linear relationship was good, and the average recoveries were 101.8%, 101.3%, 103.9%, respectively. CONCLUSION This method is simple, rapid, accurate and highly sensitive, which can be used for the determination of the residual organic solvents in sevelamer hydrochloride drug substance.