GC Determination of Residual Amounts of Acetone and Ethanol in Sodium Ibandronate Injection with Head Space

GC was applied to the determination of residual amounts of acetone and ethanol in sodium ibandronate injection with head space.The equilibrium temperature and time of head space were set at 70 ℃ and 40 min.The analyte was separated on CP-WAX capillary chromatographic column (30 m×0.25 mm,0.25 μm) and detected by FID.Linear relationship between values of peak area and mass concentration of acetone was kept in the range of 0.05-120 mg·L-1 with detection limit (3S/N) of 0.015 mg·L-1.Linear relationship between values of peak area and mass concentration of ethanol was kept in the range of 0.25-120 mg·L-1 with detection limit (3S/N) of 0.25 mg·L-1.Values of recovery found by standard addition method were in the range of 97.0%-112% for acetone and of 94.9%-112% for ethanol.Values of RSD′s (n=6) of peak area found were 2.2 % for acetone and 2.5% for ethanol.