Quality Evaluation of Shumian Capsules Based on HPLC-ELSD Fingerprint and Stoichiometry

OBJECTIVE To establish the HPLC-ELSD fingerprint of Shumian capsules and combine it with stoichiometry to comprehensively and systematically evaluate the quality of Shumian capsules. METHODS The chromatographic column was ACE Excel AR C₁₈(4.6 mm×250 mm, 5.0 μm), the mobile phase was acetonitrile-water for gradient elution at a flow rate of 1.0 mL·min^-1, the columm temperature was 30℃, ELSD evaporator tube temperature was 50℃ and the flow of N₂ was 3.0 mL·min^-1. Fifteen batches of samples were determined by HPLC-ELSD and a common mode of fingerprint was established. Based on the results, stoichiometry methods such as cluster analysis(CA), principal component analysis(PCA) were used to find main marker that caused the difference of the preparation. RESULTS There were 16 common peaks, then 10 peaks were tracked assigned and four peaks were identified as saikosaponin a, albiflorin, paeoniflorin and quercitrin. Similarities of samples were > 0.90. The CA divided the samples into three categories, and three main markers for differences between different batches, peake 3(paeoniflorin), 14 and 15 were screen out by PCA. CONCLUSION The established HPLC-ELSD fingerprint combine with HPLC-DAD fingerprint in this study can comprehensively and effectively evaluate the consistency and stability of Shumian capsules, and can provide a quality evaluation reference of Shumian capsules in the future.