ABSTRACT
Objective: To determine the nine components in Shiwei Penan Granule and establish the fingerprnt analysis for the quality control of Shiwei Penan Granule. Methods: The method was performed on a Thermo C18 column (250 mm × 4.6 mm, 5 μm); The gradient mobile phase consisted of acetonitrile (A)-0.1% phosphoric acid (B) with a flow rate of 1.0 mL/min (0-16 min, 5%-14% A; 16-20 min, 14%-17% A, 20-35 min, 17%-19% A; 35-60 min, 19%-35% A; 60-62 min, 35%-75% A; 62-78 min, 75% A); The detection wavelength was set at 230 nm (for quantitative analysis and fingerprint). Results: Gallic acid, sodium danshensu, chlorogenic acid, paeoniflorin, polydatin, benzoic acid, salvianolic acid B, emodin, and physcion were baseline seperated with good linearity relationships (r > 0.999 9) between concentration and peak areas over the linear ranges. The average recoveries of the compounds were 100.15% (RSD = 1.39%), 99.89% (RSD = 1.71%), 99.92% (RSD = 0.67%), 99.28% (RSD = 0.60%), 99.89% (RSD = 0.80%), 99.72% (RSD = 1.83%), 99.91% (RSD = 0.79%), 100.06% (RSD = 0.94%), and 99.97% (RSD = 1.36%). Using Traditional Chinese Medicine Fingerprint Similarity Evaluation System (2012 Edition) to analyze the fingerprint of 15 batches of Shiwei Penan Granule, the similarity values between the reference fingerprint and the 15 batches were higher than 0.977. Conclusion: The method is simple, rapid, and accurate, and can be used as an effective method to evaluate the quality of Shiwei Penan Granule.
ABSTRACT
In order to establish HPLC fingerprint of Liuwei Dihuang soft capsule, and to provide certain reference for an quality control of it, the HPLC method was performed on an Agilent C18 (4.6 mm x 250 mm, 5 μm) column with acetonitrile-0.02% trifluoroacetic acid as mobile phase, gradient elution volume flow of 1.0 mL x min(-1), column temperature was 30 degrees C, detection wavelength: 0-60 min, 238 nm, 60-70 min, 210 nm. The software for chromatographic fingerprint was applied to analysis different batches of Liuwei Dihuang soft capsule samples. Sixteen mutual peaks were selected as the fingerprint peaks in 12 samples with loganin as the reference peak, and all of the detected peaks were separated effectively. Cluster analysis (HCA) and similarity analysis (SA) were done based on data of 12 samples clustering analysis of 12 batches of samples were divided into 2 categories. Including 7 for the first class, the rest was second, similarities calculated by SA were all above 0.92, indicating a good similarity between the reference and twelve batches of samples, also, the analysis results of HCA and SA basically the same. This method is simple with good precision, repeatability and stability, and provides the basis for Liuwei Dihuang soft capsule quality control.