Separation and characterization of clindamycin phosphate and related impurities in injection by liquid chromatography/electrospray ionization mass spectrometry.
A simple high-performance liquid chromatography/electrospray ionization tandem mass spectrometric (HPLC/ESI-MS/MS) method has been developed for the rapid identification of clindamycin phosphate and its degradation products or related impurities in clindamycin phosphate injection. Detection was performed by quadrupole time-of-flight mass spectrometry (Q-TOFMS) via an ESI source in positive mode. Clindamycin phosphate and its related substances lincomycin, 7-epilincomycin-2-phosphate, lincomycin-2-phosphate, clindamycin B, clindamycin B-2-phosphate, and clindamycin were identified simultaneously by HPLC/ESI-MS/MS results. Based on the MS/MS spectra of their quasi-molecular ions, the fragmentation pathways of clindamycin phosphate and its related substances were compared and proposed, which are specific and useful for the identification of the lincosamide antibiotics and related impurities. The method was rapid, sensitive and specific and can be used to identify clindamycin phosphate and its related impurities in clindamycin phosphate injection without control compounds.
Wang
Shao-Min
SM
Department of Chemistry, School of Pharmaceutical Sciences, Zhengzhou University, 100 Science Road, 450001 Zhengzhou, China.
Bu
Shan-Shan
SS
Liu
Hong-Min
HM
Li
Hua-Yu
HY
Liu
Wei
W
Wang
Yu-Dong
YD
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002981:Clindamycin / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry; D004340:Drug Contamination / Q000517:prevention & control*; D007267:Injections; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*
D002981:Clindamycin; C007084:clindamycin phosphate