高效液相色谱法测定注射用盐酸米诺环素含量

THE CONTENT DETERMINATION OF MINOCYCLINE HYDROCH-LORIDE FOR INJECTION BY HPLC

目的:用高效液相色谱法测定注射用盐酸米诺环素含量。方法:采用C8柱,流动相为0.2mol/L草酸铵∶二甲基甲酰胺∶0.1mol/L乙二胺四乙酸二钠溶液(55∶25∶20),并用10%四丁基氢氧化铵调节pH值6.2～6.5,外标法,检测波长280nm。结果:回收率为99.9%,RSD%=0.40%(n=9)。结论:所用方法简便、快速、灵敏度高,可用于该品的质量控制。

Objective:To set up a new method for determing the contents of minocycline hydrochloride for injection by HPLC.Method:C 8 BDS(HYPERSIL)column (5μm,4.6×150mm)was used and mobile phase was consisted of0.2mol/L ammonium oxalate,dimethylformamidw,and0.1mol/L disodium edetate(55∶25∶20)and adjusted with10%tetrabutylammonium hydroxide to a pH between6.2and6.5for optimal resolution by chromatography.The detection wavelength was280nm.Results:The recovery rate of minocycline is99.9%,RSD%=0.40%(n=9).Conclusion:The method is easy,quick and sensitive and can be used in quality control for minocycline hydrochloride.