HPLC Fingerprint Analysis and Multiple Ingredients Determination of Sanse Powder Gel Paste

OBJECTIVE  To develop a HPLC method for the figerprint analysis and multiple ingredients determination of Sanse powder gel paste and provide a basis for the quality control.METHODS  HPLC analysis was performed on a Hypersil Gold C₁₈ column (250 mm×4.6 mm, 5 μm) with a gradient mobile phase of acetonitrile-0.1% phosphoric acid at a fow rate of 1.0 mL/min. The detection wavelength was set at 240 nm and the column temperature was set at 30 ℃. The sample volume was 20 μL, and the HPLC fingerprints of Sanse powder gel paste were established. Similarity evaluation of 10 batches of Sanse powder gel paste were evaluated by using "The similarity evaluation system for chromatographic fingerprint of traditional Chinese medicine" (2012A Version). The content of the 12 components were determined by the external standard method and mixed control solution.RESULTS  The HPLC fingerprints of Sanse powder gel paste were established under the selected chromatographic conditions, and a total of 16 common peaks were calibrated. 12 components were identified by standard comparison, and the similarity of the 10 batches of Sanse powder gel paste ranged from 0.943 to 0.994. The 12 components were all showed good linearity in a certain concentration range with the correlation coefficients greater than 0.999 1. The average recoveries were between 95.35% and 99.43% with the RSD less than 3%. The contents of 12 substances in 10 batches of preparations were basically the same.CONCLUSION  The HPLC fingerprinting method and assay are reproducible, stable and reliable for the quality control of Sanse powder gel paste.