测定注射用灯盏花乙素含量测定的两种方法研究
作者:
作者单位:

1. 昆药集团股份有限公司药物研究院,云南 昆明 650100;
2. 云南中医学院,云南 昆明 650500

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R286.0

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基金项目: 云南省重点新产品开发计划项目(2014BC009)
作者简介: 董知旭(1986-),男,云南墨江人,助理工程师,主要从事新药开发质量研究工作。E-mail:dongzhixu668@163.com


Determination of Two Methods for Determination of the Content of Scutellarin for Injection
Author:
Affiliation:

1. Drug Research Institute of Kunming Pharmaceutical Group Co., Ltd., Kunming 650100, China;
2. Yunnan University of Traditional Chinese Medicine, Kunming 650500, China

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    摘要:

    目的 用紫外分光光度法和高效液相色谱法测定注射用灯盏花乙素中灯盏花乙素的含量。方法 紫外分光光度法用甲醇作为溶剂,选择335nm作为测定波长。高效液相色谱法采用Luan C18(150×4.6 nm)作为分析柱,流动相为0.05%的磷酸水—乙腈梯度洗脱,柱温35℃,流速1 mL/min,检测波长335 nm。结果 紫外分光光度法,灯盏花乙素在5.0~15.0μg/mL范围内与吸光度呈良好线性关系(r=0.999 85),平均回收率为99.20%(n=9),RSD=0.82%(n=9),精密度与重复性RSD良好,分别为0.15%和0.93%;高效液相色谱法,灯盏花乙素在10.0~80.0 μg/mL范围内与峰面积呈良好的线性关系,r=0.999 8,平均回收率为100.69%. 结论 紫外分光光度法虽然简便、快速,但专属性不好,易受外界环境影响。所以综合考虑选择用高效液相色谱法测定注射用灯盏花乙素含量比较优。

    Abstract:

    Objective To determine the content of the injection Breviscapine by UV spectrophotometry and high performance liquid chromatography. Methods UV spectrophotometry using methanol as solvent, choose 335nm as wavelength. High performance liquid chromatography using Luan C18(150×4.6nm) as analytical column and the mobile phase was 0.05% phosphate water-acetonitrile gradient Elution. The column temperature was 35 ℃, the flow rate was 1mL/min, the detection wavelength was set at 335 nm. Results UV spectrophotometry, Breviscapine in 5. 0~15. 0μg/mL within the range of absorbance was linear(r=0.99985), the average recovery was 99.20%(n=9), RSD=0.82%(n=9), precision and repeatability RSD good, respectively for 0. 15% and 0. 93%; HPLC Breviscapine in 10.0~80.0μg/mL range and peak area showed a good linear relationship, r=0.9998, the average recovery was 100.69%. Conclusion Although UV spectrophotometry is simple, fast, but specificity is poor, susceptible to external environmental impacts. Therefore, considering the selective determination injection comparative advantage Breviscapine content by HPLC.

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