Determination of Residual Solvents in Clindamycin Hydrochloride by Headspace Gas Chromatography
- VernacularTitle:顶空气相色谱法测定盐酸克林霉素中有机溶剂残留量
- Author:
Benxia YANG
;
Shan HUANG
;
Yang LI
- Publication Type:Journal Article
- Keywords:
Clindamycinhydrochloride;
Residualsolvents;
Headspacegaschromatography
- From:
China Pharmacist
2014;(10):1784-1785
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a headspace capillary gas chromatography method for the determination of residual solvents in clindamycin hydrochloride. Methods:A headspace gas chromatography was used to separate the residual solvents on a DB-624 capillary column with an FID detector. The carried gas was nitrogen at a flow rate of 2ml·min-1 . The split ratio was 1∶1. The temperature of the injector was 200℃ and that of the FID was 300℃. The programmed column temperature was set as follows:maintained at 40℃ for 5 min and then raised to 200℃ at the rate of 20℃·min-1 and maintained for 10 min. The containers of headspace injector were in e-quilibrium at 80℃ for 30 min. Water was used as the solvent. The amounts of the residual solvents such as methanol,ethanol,acetone, chloroform and N,N-dimethyformamide were calculated by an external standard method. Results:The detected solvents were separated completely. The calibration curve of each solvent showed a good linear relationship (r=0. 999 1 ~0. 999 9). The average recovery was within the range of 97. 2% ~101. 2% and RSD was within the range of 0. 68% ~1. 98%(n=9). Conclusion:The method is suit-able for the determination of residual solvents in clindamycin hydrochloride.
