Abstract:
OBJECTIVE To establish the HPLC fingerprint chromatogram of Qingre Jiedu granules, and to conduct cluster analysis.
METHODS HPLC was performed on Phenomenex C
18 column(250 mm×4.6 mm, 5 μm) with the mobile phase consisted of methanol-0.1% phosphoric acid solution in gradient mode. The flow rate was 1.0 mL·min
-1 under the temperature of 30℃, with a detection wavelength of 325 nm. The similarity evaluation was carried out by
Similarity Evaluation System for TCM Chromatographic Fingerprint (2012 Edition). Cluster analysis was carried out by using SPSS 21.0 statistical software.
RESULTS The HPLC fingerprint of Qingre Jiedu granules with 22 commons peaks, and four of them were identified by comparing with reference substances. The similarity was ≥ 0.916. Fifteen batches of samples were divided into 3 categories. S1-S7 could be grouped into category Ⅰ; S8-S10 could be grouped into category Ⅱ; S11-S15 could be grouped into category Ⅲ.
CONCLUSION The established method is simple and reproducible. The fingerprint and cluster analysis results can be used for the quality control and process evaluation.