一种通过高效液相色谱法对草药拉夫恩进行标准化的新方法的开发。
Development of a New Approach for Standardization of the Herb Rafn. by High Performance Liquid Chromatography.
作者信息
Gubar Svitlana M, Materiienko Anna S, Smielova Nataliia M, Budanova Liana G, Georgiyants Victoriya A
机构信息
National University of Pharmacy, Department of Pharmaceutical Chemistry, Kharkiv, Ukraine.
National University of Pharmacy, Department of Quality, Standardization and Certification of Medicines, Kharkiv, Ukraine.
出版信息
Turk J Pharm Sci. 2020 Dec 23;17(6):593-598. doi: 10.4274/tjps.galenos.2019.71542.
OBJECTIVES
The aim of this study was the development a new, fully validated high performance liquid chromatography (HPLC) method for the quantitative analysis of secoiridoid glycosides by an active marker swertiamarin in the herb Rafn. The article describes a new approach to the standardization of and more specifically the development of a new validated HPLC method for the quantitative determination of secoiridoid glycosides by swertiamarin.
MATERIALS AND METHODS
The quantitative determination of swertiamarin was performed in isocratic mode on a Symmetry C18 column using water and acetonitrile as solvents for the mobile phase.
RESULTS
Validation characteristics of the developed method showed that it was linear in the whole range of concentrations from 0.01 mg/mL to 0.05 mg/mL swertiamarin. All validation characteristics met the established acceptance criteria.
CONCLUSION
This method can be used in the standardization of raw materials, as well as in the analysis of medicinal products and dietary supplements that include . The established chromatographic method was successfully applied for the analysis of raw materials of with the quantitative content determination of swertiamarin in the analyzed samples.
目的
本研究的目的是开发一种全新的、经过全面验证的高效液相色谱（HPLC）方法，用于通过草药拉夫恩中的活性标记獐牙菜苦苷对裂环烯醚萜苷进行定量分析。本文描述了一种标准化的新方法，更具体地说是开发一种经过验证的新HPLC方法，用于通过獐牙菜苦苷对裂环烯醚萜苷进行定量测定。
材料与方法
在Symmetry C18柱上采用等度洗脱模式对獐牙菜苦苷进行定量测定，使用水和乙腈作为流动相的溶剂。
结果
所开发方法的验证特性表明，在獐牙菜苦苷浓度从0.01 mg/mL至0.05 mg/mL的整个范围内呈线性。所有验证特性均符合既定的验收标准。
结论
该方法可用于原材料的标准化，以及包含该成分的药品和膳食补充剂的分析。所建立的色谱方法成功应用于拉夫恩原材料的分析，并对分析样品中的獐牙菜苦苷进行了定量含量测定。
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