Process of controlling the impurities of clindamycin hydrochloride
The invention provides a process of controlling the impurities of clindamycin hydrochloride, comprising a step of purifying said clindamycin hydrochloride by two-phase high performance liquid chromatography, wherein the chromatographic conditions are as follows: the detection wavelength is 200-220 nm; the column temperature is 20-40° C.; the flow rate is 0.8-1 ml/min; Mobile phase A: 0.025 mol/L potassium dihydrogen phosphate solution; Mobile phase B: Acetonitrile; and gradient elution is performed. The method of controlling impurities of the invention can solve the problem of the interference by excipients and the problem of the separation of many impurities at the same time. It also provides an effective method for setting quality standard of impurities in such a formulation.
ZHAOKE (GUANGZHOU) Ophthalmic Drug Company Limited
G B G B G B G G G C C B
G01N B01J G01N B01D G01N B01J G01N G01N G01N C07H C07H B01J
additional inventional additional inventional inventional inventional additional additional additional inventional inventional additional
Jing Xiaoyi Xiangrong Dongsheng Gang
Liu Li Dai Ni Li