Quality Evaluation of Yinqiao Jiedu Granules by HPLC Fingerprint

OBJECTIVE To establish the HPLC fingerprint of Yinqiao Jiedu granules for the quality evaluation and control. METHODS HPLC was performed on a Waters CORTECS^TM C₁₈ column (4.6 mm×150 mm, 2.7 μm) at 25℃. The mobile phase was acetonitrile-water (containing 0.1% formic acid) with gradient elution, with the flow rate as 0.5 mL·min^-1 and the detection wavelength as 245 nm. The characteristic peaks were identified by HPLC/QQQ-MS. Similarity of 28 batches samples from 28 nanufacturing enterprise were evaluated by chromatographic fingerprint similarity evaluation software. RESULTS The fingerprint of Yinqiao Jiedu granules was established and 34 peaks were detected, 30 of them were identified. The detected peaks belonged to Lonicerae Japonicae Flos, Forsythiae Fructus, Arctii Fructus, Menthae Haplocalycis Herba, Schizonepetae Herba, Glycyrrhizae Radix Et Rhizoma and Sojae Semen Praeparatum, respectively. The similarity values of 28 batches samples ranged from 0.77 to 0.99. CONCLUSION Some illegal production phenomena are found with raw materials of poor quality or less amount, and lax process control, etc. The method of fingerprint is simple, specific and reproducible. This study provides the basis of comprehensive evaluation and quality control.