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目的用HPLC-ELSD测定莪术油注射液中聚山梨酯80的含量。方法色谱柱:TSK-GEL G2000 SWXL柱(7.8mm×300 mm,5μm),流动相:20 mmol·L-1乙酸铵-乙腈(90∶10);流速为0.6 mL·min-1;ELSD条件:漂移管(气化室)温度103℃,氮气流速2.3 L·min-1。结果该测定方法线性范围为:2.259~28.235μg,线性关系良好(r=0.997 8);加样回收率为102.5%(n=6,RSD=1.73%);重复性试验的RSD为0.60%(n=6)。结论本方法快速、准确、稳定,可用于莪术油注射液中聚山梨酯80的质量控制。
Objective To determine the content of Polysorbate 80 in Ezhu oil injection by HPLC-ELSD. Methods Chromatographic column: TSK-GEL G2000 SWXL column (7.8 mm×300 mm, 5 μm), mobile phase: 20 mmol·L-1 ammonium acetate-acetonitrile (90∶10); flow rate of 0.6 mL·min-1; ELSD conditions : Drift tube (vaporization chamber) temperature 103°C, nitrogen flow rate 2.3 L·min-1. Results The linear range of the determination method was: 2.259~28.235μg, the linear relationship was good (r=0.997 8); the recovery rate of the sample added was 102.5% (n=6, RSD=1.73%); the RSD of the repeatability test was 0.60% ( n=6). Conclusion This method is rapid, accurate and stable and can be used for the quality control of Polysorbate 80 in Ezhu oil injection.