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HPLC 法测定紫连搽剂中左旋紫草素的含量及两种不同计算方
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篇名: HPLC 法测定紫连搽剂中左旋紫草素的含量及两种不同计算方
TITLE:
摘要:

目的:建立测定紫连搽剂中左旋紫草素含量的方法,并对测定结果的两种不同计算方法进行不确定度评价。方法:采用

高效液相色谱法。色谱柱为Waters C18,流动相为甲醇-0.025 mol/L 磷酸(85 ∶15,V/V),流速为1.0 ml/min,检测波长为516 nm,柱温

为室温,进样量为10 μl。对标准曲线法、外标一点法计算含量的过程和步骤进行量化分析,评价其不确定度。结果:左旋紫草素

检测质量浓度线性范围为4.024~80.48 μg/ml;精密度、稳定性、重复性试验的RSD<2.0%;加样回收率为RSD为88.5%~93.1%,

RSD为2.0%(n=6)。用标准曲线法测定含量,其扩展不确定度为0.70 μg/ml;用外标一点法测定含量,其扩展不确定度为0.30 μg/

ml。结论:外标一点法测定紫连搽剂中左旋紫草素的含量更经济,更便捷,引入的不确定度更低。

ABSTRACT:

OBJECTIVE:To establish a method for the content determination of L-shikonin in Zilian liniment and evaluate the

uncertainty by 2 calculation methods. METHODS:HPLC was performed on the column of Waters C18 with mobile phase of methanol-

0.025 mol/L phosphate(85 ∶15,V/V)at flow rate of 1.0 ml/min,the detection wavelength was 516 nm,column temperature was

room temperature,and the injection volume was 10 μl. Quantitative analysis was conducted for the process and procedures calculated

by standard curve method and external standard method,and the uncertainty was evaluated. RESULTS:The linear range of L-shikonin

was 4.024-80.48 μg/ml;RSDs of precision,stability and reproducibility test were lower than 2.0%;recovery was 88.5%-93.1%

(RSD=2.0%,n=6). Standard curve method was used to determine the content,and the expanded uncertainty was 0.70 μg/ml;external

standard method was used to determine the content,and the expanded uncertainty was 0.30 μg/ml. CONCLUSIONS:Standard

curve method is more economical,more convenient and lower uncertainty in the content determination of L-shikonin in Zilian

liniment.

期刊: 2015年第26卷第36期
编辑: 张红梅,姜潇,刘学起
AUTHORS: ZHANG Hong-mei,JIANG Xiao,LI Xue-qi
关键字: 左旋紫草素;紫连搽剂;含量测定;不确定度
KEYWORDS: L-shikonin;Zilian liniment;Content determination;Uncertainty
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