OBJECTIVE: To establish HPLC fingerprint of Zhenqi fuzheng granules. METHODS: HPLC-ELSD method was adopted. The determination was performed on Agilent Zorbax Eclipse XDB-C18 column with mobile phase consisted of acetonitrile-water (gradient elution) at the flow rate of 1.0 mL/min with column temperature of 40 ℃. The detector evaporation temperature was 50 ℃, and sample size was 10 μL. Using specnuezhenide as reference, HPLC chromatograms of 7 batches of Zhenqi fuzheng granules were determined. The identification and similarity evaluation of common peaks were conducted by using the TCM Chromatographic Fingerprint Similarity Evaluation System (2004 A edition). RESULTS: There were 13 common peaks in HPLC chromatograms of 7 batches of samples. After validated, the similarity of 3 batches of samples in HPLC chromatograms of 7 batches of samples were higher than 0.9, which were in good agreement with control fingerprints. The similarity of 4 batches of samples were <0.9,which were poorly same to control fingerprint. CONCLUSIONS: Established fingerprint can provide reference for quality evaluation of Zhenqi fuzheng granules.
关键词
贞芪扶正颗粒高效液相色谱-蒸发光散射检测法指纹图谱质量标准
Keywords
Zhenqi?fuzheng?granulesHPLC-ELSDFingerprintQuality standard