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Abstract: For quality control of Chinese materia medica (CMM), an attempt on fingerprint–efficacy study of artificial Calculus bovis was developed in this work. Chemical fingerprints of artificial C. bovis samples from ten different sources were determined by UPLC–ELSD and investigated by similarity analysis and hierarchical clustering analysis. Antibacterial effects of these samples on Escherichia coli growth were measured using microcalorimetry. The fingerprint–efficacy relationship of chemical fingerprint and antibacterial effect of artificial C. bovis were established by multi-linear regression analysis. Our results showed that the sources and places of production of artificial C. bovis had some important influence on the chemical fingerprints and antibacterial effects of this CMM. These artificial C. bovis could be grouped into four clusters according to their chemical fingerprints and antibacterial effects. Compounds cholic acid, taurocholate sodium, hyodeoxycholic acid and one unknown compound might be the major effective components for quality control of this CMM. Fingerprint–efficacy study provided a powerful way and some insight for the quality control of artificial C. bovis and other CCMs. [Copyright &y& Elsevier]

Abstract: A reverse phase ultra-performance liquid chromatography coupled with evaporative light scattering detection (UPLC–ELSD) method was successfully established for simultaneous determination of five bile acid derivatives in Calculus Bovis and its medicinal preparations using a Waters Acquity UPLC T3 C18 column (2.1×50mm, 1.8μm) with gradient elution of 0.2% aqueous formic acid and acetonitrile. The influence of liquid flow-rate and column temperature, gas flow-rate and drift tube temperature on resolution was investigated to get the optimized parameters and conditions. This method was validated according to the regulatory guidelines with respect to precision, accuracy and linearity. Under optimum conditions, the five analytes were baseline separated in 11min with detection and quantification limits ranged in 3.0–6.0ng and 6.0–18.0ng, respectively, which provided about a twofold reduction in analysis time and good efficiency and sensitivity by comparing a conventional high performance liquid chromatography (HPLC) method. [Copyright &y& Elsevier]