JIN Shun-qi, KANG Yue-qi, HUANG Fei, ZHANG Lu-rong
Objective: To establish the high-performance liquid chromatography (HPLC) fingerprint of Sanhuang Capsules, a hospital's drug product, and carry out the attribution analysis of its common peaks, so as to provide a reference for the improvement of its specifications. Methods: An Agilent Extend-C18 column (250 mm×4.6 mm, 5 μm) was used with methanol-phosphoric acid solution (pH 2.5) as the mobile phase for gradient elution. The flow rate was 1 mL/min, column temperature was 30 ℃, detection wavelength was 280 nm, and injection volume was 10 μL. The fingerprint was established by analyzing 10 batches of Sanhuang Capsules samples. The identification and attribution analysis of common peaks were performed by comparison with reference standards, as well as chromatograms of single herb and negative herb samples. Results: The HPLC fingerprint of Sanhuang Capsules was established, with 40 common peaks calibrated and the similarities not smaller than 0.998. Eleven components were successfully identified, namely berberine hydrochloride, baicalin, quercetin, wogonoside, baicalein, wogonin, aloe-emodin, rhein, emodin, chrysophanol and physcion. After attribution analysis, 11 peaks were confirmed to be derived from Rhei Radix et Rhizoma, 14 peaks from Scutellariae Radix, and 3 peaks from Phellodendri Chinensis Cortex. Peaks 21 and 22 were common to Rhei Radix et Rhizoma and Scutellariae Radix, while peak 11 was common to Scutellariae Radix and Phellodendri Chinensis Cortex. Conclusion: The established HPLC fingerprint method is stable and reliable, which can comprehensively characterize the overall chemical characteristics of Sanhuang Capsules. It provides a scientific basis for the subsequent establishment of multi-index component determination method and further improvement of its quality control standard