Determination of Nine Residual Organic Solvent in Clindamycin Palmitate Hydrochloride by GC

OBJECTIVE To establish a method of capillary gas chromatography for the determination of residual solvents in clindamycin palmitate hydrochloride. METHODS Ethanol, acetone, acetonitrile, dichloromethane, acetic ether and trichlormethane were separated on DB-624 capillary column through head-space sampling mode. The column temperature was maintained at 60 ℃ for 10 min, then was raised to 180 ℃ at the rate of 20 ℃·min^-1 and maintained at 180 ℃ for 2 min. The sample was dissolved in dimethylformamide-water (1∶4). Pyridine, toluene and dimethylformamide were separated on DB-624 capillary column through direct sampling mode. The column temperature was 90 ℃. The sample was dissolved in dichloromethane. RESULTS The measured solvents were separated completely. The calibration curve of each solvent showed a good linear relationship with precision and accuracy. CONCLUSION The established method is simple, reliable, which can be used for determination of residual solvents in clindamycin palmitate hydrochloride.