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  • Separation and characterization of clindamycin phosphate and related impurities in injection by liquid chromatography/electrospray ionization mass spectrometry.

Separation and characterization of clindamycin phosphate and related impurities in injection by liquid chromatography/electrospray ionization mass spectrometry.

Rapid communications in mass spectrometry : RCM (2009-02-18)
Shao-Min Wang, Shan-Shan Bu, Hong-Min Liu, Hua-Yu Li, Wei Liu, Yu-Dong Wang
ABSTRACT

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.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Clindamycin 2-phosphate, aminoglycoside antibiotic
Supelco
Clindamycin Phosphate, Pharmaceutical Secondary Standard; Certified Reference Material
Clindamycin phosphate, European Pharmacopoeia (EP) Reference Standard