关键词: 定量检测, 高效液相色谱, 三波长融合指纹图谱, 系统指纹定量法, 银翘解毒片, 主成分分析

Abstract:

The fusion high performance liquid chromatographic fingerprint combined with quantification and principal component analysis (PCA) was successfully developed, which was applied to assess the quality consistency of 25 Yinqiaojiedu tablets (YQJDTs). The resolution index I was employed as an objective function to evaluate chromatographic conditions. The chromatographic fingerprints were established by reversed-phase high performance liquid chromatography. The wavelengths were set at 230, 279 and 327 nm, separately. Then, the three wavelength fusion fingerprint was developed by the technique of multi-wavelength fusion fingerprint. The linearity, precision, repeatability, stability and accuracy of the method were proved to meet the fingerprint analysis criteria. Subsequently, the systematic quantified fingerprint method was applied for integrative quality discrimination of YQJDTs from both qualitative and quantitative perspectives. The results showed that the quality of 25 YQJDTs from the two manufacturers were completely qualified and well differentiated. The contents of six components were determined simultaneously and combined with fingerprint analysis. It was used to evaluate the quality of YQJDT from the overall and partial points of view. In addition, the PCA of the fusion fingerprint data was applied to get the score plot. It can be clearly distinguished the 25 YQJDT samples from the two manufacturers. The method proposed in this study was comprehensive and reliable, which could be used for a valuable reference to scientifically evaluate and effectively control the quality of YQJDT.

Key words: high performance liquid chromatography (HPLC), principal component analysis (PCA), quantitative determination, systematic quantified fingerprint method, three wavelength fusion fingerprint, Yinqiaojiedu tablet (YQJDT)