Comprehensively Evaluating the Quality Consistency of Liuwei Dihuang Pill by Five-Wavelength Overall Fused HPLC Fingerprints Combined with Simultaneous Determination and Antioxidant Activity.

A combination method of five-wavelength overall fused fingerprints and multi-component quantification by high-performance liquid chromatography coupled with diode array detection was developed to monitor the quality consistency of a Traditional Chinese Medicine (TCM), Liuwei Dihuang Pill (LDP). The validation results demonstrated that this method met the requirements of fingerprint analysis and quantification analysis with desired linearity, precision, accuracy, LOD and LOQ. In the fingerprint assessments, the five-wavelength overall fused fingerprints were estimated by the quantified ratio fingerprint method from qualitative and quantitative perspectives, achieved by an in-house developed software "Digitized Evaluation System for Super-Information Characteristics of TCM/HM Fingerprints 4.0". In order to holistically reflect the quality of LDP, simultaneous analysis of the content of five marker compounds was also carried out. The correlation results between quantified fingerprints and quantitative determination demonstrated that multi-component quantification could be replaced by quantified fingerprints. In addition, the fingerprint-efficacy was also established and confirmed through the partial least squares to visualize the quality information of LDP. The study demonstrated that five-wavelength overall fused fingerprints combined with antioxidant activity assay provided a reliable and efficient method for the assessment of quality of TCM and herbal preparations.