高效液相色谱联用共振光散射法测定注射用硫酸异帕米星的含量

摘要

High performance liquid chromatography ( HPLC) coupled with resonance light scattering ( RLS) method were established for determination of the isepamicin sulfate in the injection.The chromatographic separation was performed on a Agilent ZORBAX SB C18 (4.6 mm ×250 mm, 5 μm) column.The mobile phase was consisted of water:acetonitrile=97:3(φ) at flow rate of 0.5 mL/min, the fluorescence detertor was set at λex =λem =488 nm, Titan Yellow of 20 μg/mL with the BR solution was chosen as molecular recognition probe , and the flow rate of probe solution was 0.20 mL/min at post-column.The concentration of isepamicin in the linear range of 5.0 ~30.0 μg/mL had a good linear relationship , the detection limit was 1.0 μg/mL, low, and medium and high three kinds of recoveries are greater than 98%.The method was simple , more accurate and sensitivity , and provided an effective way in quality control of isepamicin sulfate injection.%用高效液相色谱-共振光散射检测法测定了注射用硫酸异帕米星的含量。采用Agilent ZORBAX SB-C18（4.6 mm ×250 mm，5μm）为色谱柱，流动相为水砄乙腈＝97：3（φ），流速0.5 mL/min，荧光检测器λex ＝λem ＝488 nm，探针达旦黄为20μg/mL的BR溶液，单泵流速0.20 mL/min。结果表明：异帕米星在5～30μg/mL浓度范围内有良好的线性关系，检测限为1.0μg/mL；高、中、低三种浓度的回收率均大于98％。本方法操作简便，方法的精密度、准确性均能满足制剂质量控制的要求，为硫酸异帕米星含量测定提供了一种新的方法。