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  • Author or Editor: H. Cao x
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Shenqi Fuzheng Injection (SFI) is a traditional Chinese medicine injection, widely used to enhance immune function of clinical cancer patients undergoing chemotherapy. In this study, a high-performance liquid chromatography-diode array detection-evaporative light scattering detection (HPLC-DAD-ELSD) method was established for quality control of SFI, which could simultaneously semiquantitatively reflect the constituents displayed in the chromatographic profile of SFI. The relative retention time and relative peak areas of the 21 common peaks related to the reference peak were calculated. The validity and advantage of this method were validated by systematically comparing chromatograms of 10 batches of SFI samples with the analytical methods of principal component analysis and angle cosine method recommended by the State Food and Drug Administration of China. Moreover, a total of 21 constituents of SFI were identified or tentatively characterized in the fingerprint via ultrafast liquid chromatography-diode array detection-quadrupole time-of-flight (UFLC-DAD-Q-TOF) tandem mass spectrometry technique on the basis of the retention time, ultraviolet spectra, fragmentation patterns, and reported literatures. All the results proved that the technique was useful in comprehensive quality evaluation of SFI and further study.

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Summary

A reversed-phase chiral liquid chromatographic method had been developed and validated for resolution of the enantiomers of racemic fudosteine. The effects on the separation of the amounts of anhydrous cupric sulfate and l-phenylalanine, the methanol content, mobile phase pH, and temperature were investigated. The method was validated for linearity, repeatability, intermediate precision, sample recovery, solution stability, and limits of detection (LOD). l-Phenylalanine and anhydrous cupric sulfate as chiral ligand-exchange complexes were used for separation, isomer identification, related substance investigation, and analysis of fudosteine enantiomers in fudosteine bulk drugs and fudosteine tablets.

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