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

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 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 m·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.