摘要
目的:建立慢肾康颗粒高效液相色谱(HPLC)指纹图谱,并测定其有效成分丹酚酸B含量,为慢肾康颗粒的综合质量控制提供参考.方法:采用HPLC法,Welch Ulimate Plus C18色谱柱(4.6 mm×250 mm,5 μm),以乙腈-0.1％磷酸溶液为流动相,梯度洗脱,流速1.0mUmin,检测波长260nm、280nm,柱温30℃,建立慢肾康颗粒指纹图谱,并在最佳条件下对丹酚酸B进行含量测定.结果:建立的慢肾康颗粒HPLC指纹图谱共标定12个色谱峰,通过对照品和对照药材比对,分别指认了5种化学成分和5味中药的特征峰;丹酚酸B在33.93～203.58 μg/mL范围内呈良好的线性关系(r=0.999 7),稳定性、重复性试验的RSD值均小于3.0％,平均加样回收率为103.30％,RSD值为1.35％.结论:本研究建立的HPLC指纹图谱及含量测定方法准确,重复性和稳定性好,可以为慢肾康颗粒质量控制提供参考.
Abstract
Objective:To establish the high performance liquid chromatograph(HPLC)fingerprints for Manshenkang Granules(慢肾康颗粒),and to determine the contents of salvianolic acid B,then to provide a reference for the quality control of Manshenkang Granules.Methods:HPLC was used to establish the fingerprint of Manshenkang Granules.The separation was performed on a 30 ℃ Welch UlimatePlus C18 column(4.6 mm× 250 mm,5 μm)by using a gradient elution with acetonitrile-0.1％phosphoric acid aqueous solution.The flow rate was 1.0 mL/min and the detection wavelength was set as 260 nm and 280 nm.The content of salvianolic acid B was also determined under optimal conditions.Results:There were 12 chromatographic peaks calibrated in the HPLC fingerprints of Manshenkang Granules.And the characteristic peaks of 5 chemical components and 5 medicinal materials were identified by the comparison of reference substance and reference medicinal materials.Salvianolic acid B showed a good linear relationship in the range of 33.93 to 203.58 μg/mL(r=0.999 7).The RSD of stability and repeatability tests were both less than 3.0％,and the average recovery rate was 103.30％with the RSD of 1.35％.Conclusion:The HPLC fingerprint and content determination method estab-lished in this study is accurate,repeatable and stable,which can provide a reference for the quality control of Manshenkang granules.
维普
万方数据