Determination of Residual Organic Solvents in Tandospirone Citrate by GC

OBJECTIVE To develop a headspace GC method for the determination of residual organic solvents such as methanol, ethanol, iso-propyl alcohol, ethyl acetate, methylbenzene, N,N-dimethylformamide in tandospirone citrate. METHODS Headspace GC was adopted using a DB-624 column(30m×0.32mm, 1.80 μm), the column temperature was maintained at 40 ℃ for 5 min, then was raised to 220 ℃ at the rate of 20 ℃·min^-1 and maintained at 220 ℃ for 2?min. The injection port temperature was 200 ℃; the FID detector temperature was 250 ℃; the sample was dissolved in DMSO. RESULTS Six residual solvents were separated completely. It was appeared to present a good linearity within the experimental concentration, and the precision and recoveries were good. CONCLUSION The method can be used for the determination of the residual solvents in tandospirone citrate.