HPLC-ELSD法测定聚乙二醇4000散剂中聚乙二醇4000的含量

目的: 建立高效液相色谱－蒸发光散射检测(HPLC-ELSD)法测定聚乙二醇4000散剂中聚乙二醇4000的含量。 方法: 采用Venusil XBP-C₈色谱柱(150 mm×4.6 mm,5 μm),以甲醇－水为流动相进行梯度洗脱,流速1.0 mL· min^-1,柱温35 ℃;Alltech ELSD-2000检测器,漂移管温度:80 ℃,载气为空气,流速:2.8 L· min^-1。 结果: 聚乙二醇4000线性范围为0.5~1.5 mg·mL^-1(r=0.9995),回收率为101.3%。 结论: 本方法准确、简便、快速,重复性好,可用于聚乙二醇4000散剂的含量测定。

Objective: To approach an assay method of determination for macrogol 4000 in macrogol 4000 powder by HPLC-ELSD method. Methods: The assay was performed on Venusil XBP-C₈ column(150 mm×4.6 mm,5 μm)with a gradient program of methanol-water as the mobile phase and an Evaporative Light-Scattering Detector(Alltech ELSD-2000) as the detector. The drift tube temperature was 80 ℃, the gas flow rate was 2.8 L· min^-1.Column temperature: 35 ℃. Results: The line ranges of macrogol 4000 was 0.5-1.5 mg·mL^-1(r=0.9995). The average recoveries (n=9) of macrogol 4000 was 101.3%. Conclusion: The method is proved to be rapid, accurate and convenient, and provided a reliable way for evaluating the quality of macrogol 4000 powder.