引用本文: | 唐登峰,祝明,陈碧莲,郑成,张鹏,方丽.HPLC-ELSD测定莪术油注射液中聚山梨酯80的含量[J].中国现代应用药学,2011,28(5):462-465. |
| TANG Dengfeng,ZHU Ming,CHEN Bilian,ZHENG Cheng,ZHANG Peng,FANG Li.Determination of Polysorbate 80 in the Zedoary Turmeric Oil Injection by HPLC-ELSD[J].Chin J Mod Appl Pharm(中国现代应用药学),2011,28(5):462-465. |
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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。 |
关键词: 莪术油注射液 高效液相色谱-蒸发光散射检测法 聚山梨酯80 含量测定 |
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Determination of Polysorbate 80 in the Zedoary Turmeric Oil Injection by HPLC-ELSD |
TANG Dengfeng,ZHU Ming,CHEN Bilian,ZHENG Cheng,ZHANG Peng,FANG Li
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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. |
Key words: Zedoary turmeric oil injection HPLC-ELSD polysorbate 80 content determination |