Determination of Residual Organic Solvents in Reloxifene Hydrochloride by Capillary Column Headspace Injection Method

A capillary column headspace injection method for the determination of residual methanol, tetrahydrofuran, dichloroethane, pyridine and toluene in reloxifene hydrochloride was established. 5% Phenyl methyl siloxane capillary column was used, with dioxane as the internal standard. The average recoveries of methanol, tetrahydrofuran, dichloroethane, pyridine and toluene was 99.2%( RSD 0.8%),99.2%( RSD 0.7%),99.4%( RSD 0.7%),100.4%( RSD 0.9%) and 99.8%( RSD 0.3%), respectively. The linear ranges were 1.6~32.6, 0.44~8.86, 0.66~13.2,9.83~88.47 and 0.43~8.67 μg/ml, respectively.