Analysis of pharmaceutical samples of Resina Draconis by HPLC-PAD

Introduction: The quality evaluation of traditional Chinese medicine (TCM) represents a particular challenge owing to the complexity of the matrix, which renders separation and identification of the individual components extremely difficult. In recent years, fingerprinting of TCMs has played a dominant role in quality control. Resina Draconis was authorised as a new TCM in 1991, but a satisfactory HPLC fingerprint method for this preparation has not yet been published. Objective: To develop a simple and reliable protocol for the quality control of Resina Draconis using an HPLC‐PAD method. Methodology: The TCM was extracted with methanol at room temperature. Chromatography was carried out using a Lichrospher C₁₈ column eluted with a linear gradient of acetonitrile (A) and water containing 0.1% phosphoric acid (B), initially at 30:70 (A:B) and changing to 60:40 in 90 min. UV (PAD) spectra were acquired in the range 210–400 nm. Results: Four chromatograms of samples of Resina Draconis obtained from different pharmaceutical factories showed 20 peaks in common. The average chromatogram was taken as a template from which the correlation coefficients and cosine ratios of the samples were determined. Whereas the contents of individual components in each sample were different, overall the samples were extremely similar one to another, and the products from different pharmaceutical factories were consistent. Conclusion: A reliable and validated HPLC method has been developed for the fingerprint analysis of Resina Draconis that can be applied for the quality control of this TCM. Copyright © 2008 John Wiley & Sons, Ltd.