Objective: To establish an HPLC method for characteristic chromatograms analysis and simultaneous determination of six marker components in Xinnaojian Capsules from different manufactories.

Methods: Using HPLC, an Agilent C18 column (100 mm x 4.6 mm, 2.7 μm) was adopted with acetonitrile-0.05% phosphoric acid as the mobile phase in a gradient elution mode, the flow ratewas 0.4 mL/min, the detection wavelength was 280 nm, and the column temperature was 40 degrees C.

Results: Totally eleven common peaks were recognized with epigallocatechin-3-gallate as the reference peak. There were good similarities between the standard characteristic chromatogram and each characteristic chromatogram of the 26 samples with their similarities over 0.99. The six marker components (gallic acid, gallocatechin, caffeine, epigallocatechin, epigallocatechin-3-gallate and epicatechin gallate) were separated well. Good correlation coefficients were found (r > 0.9990) and the average recovery rates ranged from 95.29% to 102.3%.

Conclusion: The established method has high sensitivity and specificity, and can be used for the quality control of Xinnaojian Capsules.

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