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采用 HPLC-DAD 进行定量分析结合色谱指纹图谱对丹红注射液进行综合评价。

Quantitative analysis combined with chromatographic fingerprint for comprehensive evaluation of Danhong injection using HPLC-DAD.

机构信息

College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.

出版信息

J Pharm Biomed Anal. 2013 Mar 25;76:70-4. doi: 10.1016/j.jpba.2012.12.013. Epub 2012 Dec 20.

Abstract

A simple, reliable method for simultaneous determination of the ten components in Danhong injection (DHI) in combination of chromatographic fingerprint analysis was developed by high performance liquid chromatography coupled with diode-array-detector (HPLC-DAD). The separation was performed on an Agilent Zorbax SB-C(18) column with a linear gradient elution of acetonitrile and 0.5% formic acid. The method was validated by linearity, precision, stability and recovery. The developed method was subsequently applied to evaluate 15 batches of DHI and testified to be suitable for its quality control.

摘要

建立了一种高效液相色谱-二极管阵列检测法(HPLC-DAD)结合色谱指纹图谱分析同时测定丹红注射液中 10 个成分的简单、可靠的方法。采用 Agilent Zorbax SB-C(18)柱,以乙腈和 0.5%甲酸为流动相进行梯度洗脱。该方法通过线性、精密度、稳定性和回收率进行了验证。所建立的方法随后用于评估 15 批丹红注射液,并证明适用于其质量控制。

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