高效液相色谱法测定舒血宁注射液总黄酮醇苷的含量

Determination of total flavonoid glycosides in Shuxuening injection by HPLC

关键词:  舒血宁注射液  槲皮素  山奈酚  异鼠李素  总黄酮醇苷

Key words:  Shuxuening injection  quercetin  kaempferol  rhamnetin  total flavonoid glycosides

摘要:

[目的]建立舒血宁注射液中总黄酮醇苷含量测定方法，为其质量控制提供技术手段。[方法]采用Extend-C18柱（4.6 mm×250 mm，5 μm），以乙腈-0.1%甲酸水（v/v）为流动相，梯度洗脱，流速为1 mL/min，进样体积为15 μL，柱温为35 ℃，检测波长为360 nm.[结果]槲皮素、山奈酚及异鼠李素3种黄酮的分离及线性关系良好；精密度，重复性和稳定性RSD均都小于5%；平均回收率在99.5%~100%之间且RSD均值小于5%.30批舒血宁注射液中总黄酮醇苷平均含量为1.06 mg/mL且无统计学差异。[结论]本方法简便、准确、可靠，适用于舒血宁注射液中总黄酮醇苷含量的测定，为舒血宁注射液质量控制提供了科学依据。

Abstract:

[Objective] To establish a high performance liquid chromatography (HPLC) method to determine the content of total favonol glycosidesfor quality control of Shuxuening injection. [Methods] The HPLC analysis was performed on an Extend-C18 column (4.6×250 mm, 5 μm). Acetonitrile and water containing 0.1% formic acidwas selected asmobile phrasein a gradient elution at a flow rate of 1 mL/min. The injection volume was 15 μL.The column temperature was set up at 35℃.The detection wavelength was 360nm. [Results] There were good separation and the linear relationships of quercetin、kaempferol and rhamnetin. The RSD of precision, the repeatability and stability all were less than 5%. The sample recoveriesranged from 99.5% to 100% and their RSD values were less than 5%.The averagecontent of total flavonoid glycosides in 30 batches ofShuxuening injections was 1.06 mg/mL and there was no significantly different from different batches. [Conclusion] The method could be applied to determinethe total content of flavonoid glycosides of Shuxuening injection accurately and reliably, which provide a scientific basis for the quality evaluation of Shuxuening injection.