HPLC Fingerprint Analysis of Baidianfeng Capsule / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish an HPLC chromatographic fingerprint analysis method for the quality evaluation of Baidianfeng capsule and study the differences of products from different manufacturers. METHODS: The chromatographic separation was performed on an XBridge@Shield RP18 column(4.6 mm×250 mm, 5 μm), with the mixture of methanol and 0.15% formic acid as mobile phases in gradient elution mode.The detection wave length was set at 300 nm, the flow rate was 1.0 mL•min-1 and the column temperature was maintained at 35 ℃. The similarity was evaluated with Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (version 2008). Common peaks were identified by HPLC-MS through the comparison with the references and literature. RESULTS: The precision, repeatability and stability of the established method can meet the requirements of fingerprint chromatography analysis.There were 18 common peaks were identified in the HPLC fingerprint.The similarity of 10 batches of samples ranged from 0.723 to 0.900, indicating greater differences in the qualities among the samples. CONCLUSION: The developed method could provide the comprehensive information about the chemical components in Baidianfeng capsule in a rapid reliable and convenient manner.It could be used in quality evaluation of the drug. It provides scientific basis for improving its quality standard.