Two Methods for Determination of Polysorbate 80 in Fufang Kushen Injections

LI Jian-wei; ZHOU Hong-jun; NIE Lei; JIAN Xiao-yong

doi:10.13422/j.cnki.syfjx.2014150054

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Two Methods for Determination of Polysorbate 80 in Fufang Kushen Injections

更新时间：2024-01-04

- Two Methods for Determination of Polysorbate 80 in Fufang Kushen Injections
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 20, Issue 15, Pages: 54-57(2014)
- 作者机构：
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- DOI：10.13422/j.cnki.syfjx.2014150054
  CLC： O657.72;R284.2
- Published：2014
- 稿件说明：
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LI Jian-wei, ZHOU Hong-jun, NIE Lei, et al. Two Methods for Determination of Polysorbate 80 in Fufang Kushen Injections[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(15): 54-57.
DOI：

LI Jian-wei, ZHOU Hong-jun, NIE Lei, et al. Two Methods for Determination of Polysorbate 80 in Fufang Kushen Injections[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(15): 54-57. DOI： 10.13422/j.cnki.syfjx.2014150054.

摘要

目的：建立HPLC-ELSD测定复方苦参注射液中聚山梨酯80含量的方法，并与分光光度法测定结果进行比较。方法：采用TSKgel G2000SWXL色谱柱（7.8 mm×300 mm，5 μm）及保护柱，流动相20 mmol·L-1醋酸铵-乙睛（88：12），流速0.6 mL·min-1，柱温30℃；ELSD检测条件：蒸发器温度80℃，雾化器温度60℃，氮气流速2 L·min-1，进样体积10 μL。结果：聚山梨酯80在13.11~52.42 μg呈良好的线性关系（r=0.999 2），平均回收率为100.9%，RSD 2.2%；与复方苦参注射液中聚山梨酯80理论投料量进行比较，UV法测得结果偏高，HPLC-ELSD法测定结果更接近理论值。结论：该法操作简便，重复性好，结果准确可靠，可用于聚山梨酯80含量控制。

Abstract

Objective: To establish the determination method for polysorbate 80 in Fufang kushen injections by HPLC-ELSD

compare it with UV spectrophotometry. Method: HPLC-ELSD was adopted with a TSKgeL G2000SWXL(7.8 mm×300 mm

5 μm) column. The mobile phase consisted of 0.02 mol·L-1ammonium acetate-acetonitrile (88:12) with the flow rate of 0.6 mL·min-1and the column temperature was 30℃. The temperature of drift tube was 80℃. The flow rate of N2 was 2 L·min-1. Result: The linear range of polysorbate 80 was13.11-52.42 μg (r=0.999 2)

and the average recovery was 100.9%

RSD 2.2%. Compared with the theoretical value of Polysorbate 80 in Fufang kushen injections

result of UV on the high side

results of HPLC-ELSD method was closer to the theoretical value. Conclusion: HPLC-ELSD is simple and accurate

and can be used in the determination of polysorbate 80.

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