薄层色谱法测定地红霉素中的有关物质

Study on the determination of related substances in dirithromyc in by thin-layer chromatography

目的采用薄层色谱法检查地红霉素中的有关物质。方法地红霉素供试品经无水甲醇溶解后 ,以正己烷 二氯甲烷 甲醇 浓氨水 (2∶3∶0 .8∶0 .0 6)为展开剂 ,在硅胶GF2 5 4薄层板上展开 ,以硫酸显色后观察。结果确立供试品有关物质限度。结论此法简便、灵敏、准确 。

PurposeThe aim is to control qualitatively t he rel ated substances in dirithromycin by thin-layer chromatography (TLC).Met hodsSample preparation: dirithromycin dissolved with ethanol, st ationary phase: GF 254 silicon gel, mobile phase: n-Hexane-dichlorometha ne- methanol-ammonia water(2∶3∶0.8∶ 0.06 ), sulfuric acid as colorate reagent.ResultsThe impurity limit was obtained. ConclusionThis method is simple,sensitive and accurate.It can be used for rapid quality control of the related substances in dirithromy cin.