Liu Ai-Hua, Lin Yan-Hua, Yang Min, Sun Jiang-Hao, Guo Hui, Guo De-An
The State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical Sciences, Peking University, Beijing, PR China.
J Pharm Pharm Sci. 2006;9(1):1-9.
This paper describes a validated high-performance liquid chromatographic method to quantitate four tanshinones as markers; dihydrotanshinone I, cryptotanshinone, tanshinone I and tanshinone IIA for use in the quality control of the roots of Salvia miltiorrhiza and its related traditional Chinese medicinal preparations.
Separation was achieved using a Zorbax Extend C18 reserved-phase column (5microm, 250*4.6mm) at 20 degrees with a gradient mixture of deionized water and acetonitrile at a flow rate of 1.2ml/min.
The limits of quantitation were 0.13, 0.08, 0.06 and 0.05microg/ml for dihydrotanshinone I, cryptotanshinone, tanshinone I and tanshinone IIA, respectively. This method provided good reproducibility and sensitivity for the quantification of four tanshinones with overall RSD values for intra-day and inter-day precision and accuracy better than 3.8% and higher than 94.9%, respectively. The recovery of the method was 95.4-104.4% for all the tanshinones and showed good linearity (r>0.9998) over a relatively wide concentration range.
This assay was successfully applied to the determination of four tanshinones in the roots of Salvia miltiorrhiza and its related traditional Chinese medicinal preparations. The results indicated that the HPLC assay could be readily utilized as a quality control method for the roots of Salvia miltiorrhiza and its related traditional Chinese medicinal preparations.
本文描述了一种经过验证的高效液相色谱法,用于定量测定四种丹参酮作为指标成分,即二氢丹参酮I、隐丹参酮、丹参酮I和丹参酮IIA,以用于丹参根及其相关中药制剂的质量控制。
采用Zorbax Extend C18反相色谱柱(5μm,250×4.6mm),于20℃,以去离子水和乙腈的梯度混合液为流动相,流速为1.2ml/min进行分离。
二氢丹参酮I、隐丹参酮、丹参酮I和丹参酮IIA的定量限分别为0.13、0.08、0.06和0.05μg/ml。该方法对四种丹参酮的定量具有良好的重现性和灵敏度,日内和日间精密度和准确度的总体相对标准偏差(RSD)值分别优于3.8%和高于94.9%。所有丹参酮的方法回收率为95.4 - 104.4%,在较宽的浓度范围内呈现良好的线性关系(r>0.9998)。
该测定方法成功应用于丹参根及其相关中药制剂中四种丹参酮的测定。结果表明,高效液相色谱法可作为丹参根及其相关中药制剂的质量控制方法。