三色散凝胶贴膏剂的HPLC指纹图谱研究和多元成分含量测定

目的 建立三色散凝胶贴膏剂的HPLC指纹图谱,同时对其多种成分进行含量测定,为其质量控制提供依据.方法 采用Hypersil Gold C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1％磷酸水溶液,梯度洗脱,流速为1.0 mL/min,柱温为30℃,检测波长为240 nm,进样量为20μL,建立...

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.