HPLC测定盐酸土霉素的含量和有关物质

DETERMINATION OF OXYTETRACYCLINE HYDROCHLORIDE AND RELATED SUBSTANCES BY HPLC

目的 :建立HPLC测定盐酸土霉素有关物质和含量。方法 :采用ODS柱 ( 10 μm ,4 6mm× 2 5 0mm) ,以 0 1mo1·L-1草酸铵溶液 二甲基甲酰胺 0 2mo1·L-1磷酸氢二铵溶液 ( 6 0∶30∶10 ) (用氨试液调pH8 3)为流动相 ,检测波长 2 70nm。结果 :盐酸土霉素在 0 1～ 1 0mg·ml-1浓度范围内 ,呈良好的线性关系 (r =0 9999) ,精密度RSD为1 2 % ,平均回收率为 99 6 % ,RSD为 0 8% (n =4)。结论 :该法简便、准确 ,适用于盐酸土霉素杂质的检测和含量的测定。

OBJECTIVE:An HPLC method was established to determine oxytetracycline hydrochloride and related substances METHODS:The liquid chromatographies equipped with 270 nm detector,μ Bondapak ODS column(4 6 mm×250 mm, 10 μm) The mobile phase is 0 1 mol·L -1 ammonium oxalate dimethylformamide 0 2 mol·L -1 dibasic ammoniumphosphate (60 ∶30∶10)(adjusted with 3 mol·L 1 ammonium hydroxide to pH 8 3) RESULTS:The linearity is good ( r =0 9999) in the range of 0 1～1 0 mg·ml -1 The recovery rate was 99 6%, RSD =0 8% CONCLUSION:The method is simple,accurate and is very suitable for determination of oxytetracycline hydrochloride and related substances