A micellar electrokinetic chromatography fingerprint coupled with quantification was developed for assessing the quality consistency of Danshen tablets, a traditional Chinese medicine, with pharmacological activities of activating blood to remove blood stasis and regulating the flow of vital energy to alleviate pain. Square optimization method was proposed to select the suitable background electrolyte. Subsequently, the index of chromatographic fingerprints F was simultaneously employed as an objective function to evaluate capillary electrophoresis conditions. After that, the method was proved to meet the fingerprint analysis criteria by evaluating stability, linearity, limit of detection, limit of quantification, precision, accuracy, and repeatability. Moreover, systematic quantified fingerprint method was used to evaluate chromatographic fingerprints of 30 batches of samples in terms of both quality and quantitation. The result indicated that the chemical compositions of samples were basically similar while their contents showed marked variation. In addition, the fingerprint-efficacy relationship was established using partial least squares model, which can serve as anti-oxidant activity evaluation of Danshen tablets as well as a reference for the selection of active constituents. The proposed method can be applied for the holistic quality control of Danshen tablets.
Keywords: Danshen tablet; Fingerprint-efficacy relationship; Micellar electrokinetic chromatography; Square optimization method; Systematic quantified fingerprint.
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