Determination of Residual Organic Solvents in Dimemorfan Phosphate by GC
- VernacularTitle:气相色谱法测定磷酸二甲啡烷中有机溶剂残留
- Author:
Weizhi LIU
;
Hankun HU
;
Baogen ZHENG
;
Anni LIU
;
Qiang YAN
;
Ping LIU
- Publication Type:Journal Article
- Keywords:
GC;
Dimemorfan phosphate;
Residual organic solvents
- From:
China Pharmacist
2014;(4):563-565
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To determine the content of chloroform, ethyl acetate and DMF in dimemorfan phosphate by gas chromatog-raphy (GC). Methods:The capillary gas chromatography was used with a PEG-20M column, programmed temperature, water as the solvent and FID as the detector. Results:The three organic solvents were separated and showed good linear relationship (r>0. 999 0). The detection limit of chloroform, ethyl acetate and DMF was 0. 63,0. 60 and 8. 92μg·ml-1 , respectively. The residues of the organ-ic solvents in three batches of the samples all met with the requirements of ICH. Conclusion: The method is sensitive, accurate and reliable, and can be used in the quality control of dimemorfan phosphate.
