HPLC-ELSD测定莪术油注射液中聚山梨酯80的含量

Determination of Polysorbate 80 in the Zedoary Turmeric Oil Injection by HPLC-ELSD

摘要: 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(7.8 mm×300 mm，5 μm)，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：2.259~28.235 μg，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。

Abstract: OBJECTIVE To develop an HPLC-ELSD method for the determination of polysorbate 80 in the Zedoary turmeric oil injection. METHODS The column was TSK-GEL G2000 SWXL(7.8 mm×300 mm, 5 μm). The mobile phase was 20 mmol·L^-1 ammonium acetate-acetonitrile (90∶10) at the flow rate of 0.6 mL·min^-1. The drift tube temperature was 103 ℃, and the gas flow rate of nitrogen was 2.3 L·min^-1. RESULTS The polysorbate 80 has good linearity in the range of 2.259-28.235 μg(r=0.997 8). The average recovery was 102.5%(n=6, RSD=1.73%), repeatability experiments showed that RSD(n=6) was 0.60%. CONCLUSION The method is rapid, accurate, stable, and can be used to determinate polysorbate 80 in the Zedoary turmeric oil injection.