[Determination of the components of bitespiramycin by HPLC].
The paper is to report the establishment of an HPLC method for determination of the components of bitespiramycin and its products, and to evaluate the components profile of bitespiramycin and its related products. Liquid chromatography combined with mass spectrometry (LC-MS) was used to identify the nine major components of the reference substance of bitespiramycins. The nine components of bitespiramycins and its products have been quantified by HPLC with gradients elution methods. The content of the component of 4"-O-isovalerylspiramycin III was not less than 35%, the content of the components of 4"-O-isovalerylspiramycin (I + II + III) was not less than 60%, and the contents of the nine components of bitespiramycin were not less than 80%, separately. In addition to the components mentioned above, there also exists some other impurities, however, with lower contents. This gradient elution HPLC method reported by this paper is considered to be suitable for the quality control of bitespiramycin.
Yang
Ya-Li
YL
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China. yaliyang-2008@hotmail.com
Yang
Jian-Ning
JN
Hu
Min
M
Hu
Chang-Qin
CQ
D000900:Anti-Bacterial Agents / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002853:Chromatography, Liquid / Q000379:methods; D011786:Quality Control; D015572:Spiramycin / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry; D053719:Tandem Mass Spectrometry / Q000379:methods
D000900:Anti-Bacterial Agents; C503764:bitespiramycin; D015572:Spiramycin; C423662:carrimycin