Key Takeaways & Executive Findings
- •• Developed a robust HPLC-DAD method for simultaneous determination of nine bioactive components in TCM formulations. • Method validation demonstrated excellent linearity, precision, accuracy, and robustness. • Successfully applied to quality control of a representative TCM formulation. • Provides a reliable tool for ensuring the safety and efficacy of TCM products.
Abstract
A comprehensive analytical method was developed and validated for the simultaneous determination of multiple bioactive components in traditional Chinese medicine (TCM) formulations. The method employs high-performance liquid chromatography coupled with diode array detection (HPLC-DAD) and was optimized for the separation of nine key components, including phenolic acids, flavonoids, and saponins. Chromatographic separation was achieved on a C18 column with gradient elution using a mobile phase of acetonitrile and phosphoric acid solution. The method was validated for linearity, precision, accuracy, and robustness, demonstrating excellent performance with correlation coefficients greater than 0.999. The limits of detection and quantification ranged from 0.02 to 0.15 μg/mL and 0.05 to 0.50 μg/mL, respectively. The developed method was successfully applied to the quality control of a representative TCM formulation, and the results indicated that the method is reliable and suitable for routine analysis. The study provides a valuable tool for the quality assessment of TCM products, ensuring their safety and efficacy.
1. Introduction
Traditional Chinese Medicine (TCM) has been widely used for centuries in the prevention and treatment of various diseases. The complexity of TCM formulations, which often contain multiple herbal ingredients, poses significant challenges for quality control. Ensuring the consistency and safety of TCM products requires robust analytical methods capable of simultaneously determining multiple bioactive components. High-performance liquid chromatography (HPLC) coupled with diode array detection (DAD) has emerged as a powerful technique for this purpose, offering high sensitivity and selectivity.
In this study, we aimed to develop and validate a comprehensive HPLC-DAD method for the simultaneous determination of nine key components in a representative TCM formulation. The method was optimized to achieve efficient separation and accurate quantification, and its performance was thoroughly validated according to international guidelines. The developed method is expected to contribute to the quality assessment of TCM products, supporting their safe and effective use in clinical practice.
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ZHANG Wei, LI Ming, WANG Fang, CHEN Jing, LIU Yang, ZHAO Lei, SUN Hong, ZHOU Tao, WU Gang, XU Yan (2025). Development and Validation of a Comprehensive Analytical Method for Simultaneous Determination of Multiple Components in Traditional Chinese Medicine Formulations Using High-Performance Liquid Chromatography with Diode Array Detection. Chinese Journal of New Drugs. https://doi.org/cast_zgxyzz_1236731784289907521
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Frequently Asked Questions
What is the purpose of the developed HPLC-DAD method?
The method is designed for simultaneous determination of multiple bioactive components in traditional Chinese medicine formulations, enabling comprehensive quality control.
Which components were analyzed in the study?
The study targeted nine key components, including phenolic acids, flavonoids, and saponins, which are representative of the chemical diversity in TCM formulations.
How was the method validated?
The method was validated for linearity, precision, accuracy, and robustness, with correlation coefficients >0.999 and acceptable recovery rates, ensuring reliability for routine analysis.
What are the advantages of using HPLC-DAD for TCM analysis?
HPLC-DAD offers high sensitivity, selectivity, and the ability to simultaneously monitor multiple wavelengths, making it ideal for analyzing complex TCM matrices.
Can this method be applied to other TCM formulations?
Yes, the method can be adapted and extended to other TCM formulations by optimizing the chromatographic conditions and selecting appropriate marker components.
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