Isolation and identification of impurities from raw material of clindamycin phosphate.
- Author:
Yue LI
1
;
Tong WU
;
Shu-Zeng CHEN
;
Qiu-Shi SUN
;
Li QIN
;
Ling-Yue XU
Author Information
1. Shanghai Institute of Pharmaceutical Industry, Shanghai 200040, China. liyue.cn@126.com
- Publication Type:Journal Article
- MeSH:
Anti-Bacterial Agents;
chemistry;
Chromatography, High Pressure Liquid;
Chromatography, Liquid;
Clindamycin;
analogs & derivatives;
chemistry;
Drug Contamination;
Molecular Structure;
Molecular Weight;
Spectrometry, Mass, Electrospray Ionization
- From:
Acta Pharmaceutica Sinica
2010;45(11):1415-1420
- CountryChina
- Language:Chinese
-
Abstract:
Four impurities were isolated from raw material of clindamycin phosphate (CP), and their structures have been determined. LC-MS was used to determine the molecular weights of the impurities in the raw material of CP. Reversed-phase preparative HPLC was used to prepare them, and their chemical structures were identified by HR-MS and NMR. The four unknown impurities were determined as clindamycin-B-phosphate (1), clindamycin-2,4-diphosphate (2), 3',6'-dehydro clindamycin phosphate (3), epi-clindamycin phosphate (4). Impurity 1 has been included in BP and EP, while 2, 3 and 4 have not. The impurities 2, 3, 4 are first separated from raw material of CP.