Quality assessment of Yinju Jiedu Oral Liquid based on HPLC fingerprint and multi-components simultaneous determination / 中草药

ABSTRACT

Objective: To establish the HPLC fingerprint of liquid of raw material-intermediate product-Yinju Jiedu Oral Liquid (YJOL), and to determine the multi-components in YJOL, thus to provide an approach and basis for the quality control in production. Methods: The separation was performed on Shimadzu Inert Sustain C18 columin (250 mm × 4.6 mm, 5 μm) with mobile phase composed of acetonitrile-0.1% phosphoric acid solution (gradient elution) at the flow rate of 1.0 mL/min, the column temperature was set at 30 ℃ and the detection wavelengths were set at 240, 327, 334, and 280 nm. HPLC fingerprints of the extracts from 12 batches of raw material, intermediate product, and YJOL were established and compared. The content was determined and the common peaks were identified, and some of the characteristic peaks were analyzed. Results: Fifteen common peaks of intermediate product and liquid of raw material and 13 common peaks in YJOL were determined. The similarities of YJOL were over 0.9, the same with the similarities of the liquid of raw material and intermediate product. The correlation was good between the extracts from the liquid of raw material, intermediate product and YJOL. Peak 1 was from Isatidis Radix, peaks 2-7 were from Honeysuckle of Sichuan and Chrysanthemum indicum, peaks 8 and 9 were from Chrysanthemum indicum, peaks 10 and 11 were from Scrophulariae Radix, peaks 12 and 13 were from Scurfpea fruit. Based on the retention time of master compounds, six components [R, S-epigoitrin (peak 1), chlorogenic acid (peak 3), linarin (peak 10), harpagoside (peak 11), psoralen (peak 13), and psoralen (peak 14)] were identified and quantified. The average contents of six components were 39.21, 15.43, 2.14, 0.53, 7.21, and 6.51 mg/g in raw material, were 35.31, 11.54, 1.83, 0.37, 4.95, and 4.74 mg/g in intermediate product, and were 32.87, 10.58, 1.72, 0.31, 4.58, and 4.48 mg/g in YJOL. Conclusion: This validated method is suitable for the quality evaluation and quality control of YJOL.