HPLC-ELSD法分析硫酸链霉素的含量

Content determination of streptomycin sulfate by HPLC-ELSD

目的建立一种硫酸链霉素的含量分析方法。方法应用高效液相色谱-蒸发光散射检测法分析硫酸链霉素的含量。色谱条件:Waters XTerra C18色谱柱,规格:250mm×4.6mm,5μm;流动相:0.1mol/L三氟乙酸水溶液-0.1%(v/v)甲酸水溶液(40:60);检测器条件:汽化温度为105℃,雾化温度为50℃,气体流速1.90SLM。结果硫酸链霉素样品中主成分与相邻杂质分离良好,主成分峰型及进样峰面积重现性良好,在选定进样量范围内线性良好。结论本方法操作简单,方法的准确性、重现性均能很好的满足质量控制的要求。

Objective To establish an HPLC-ELSD method for content determination of streptomycin sulfate. Methods The column： Waters XTerra C18（250mm × 4. 6mm,5μm）; the mobile phase： 0. lmol/L trifluoroacetatic acid- 0. 1% （v/v） formic acid （40： 60）; vaporizing temperature： 105℃, nebulizing temperature： 50℃; gas flow rate： 1.90SLM. Results The resolution between streptomycin and impurities was fine. Reproducibility was satisfactory. The linear of streptomycin concentration and ELSD response was good. Conclusion The method was simple, accurate, reliable and could be used for the quality control of streptomycin.