Quality Evaluation of Jieyu Pills Based on UPLC Fingerprint Chromatogram and Multi-component Content Determination

OBJECTIVE To establish the fingerprint chromatogram and multi-component content determination method of Jieyu pills based on ultra performance liquid chromatography(UPLC), to provide reference for its scientific and comprehensive quality control and evaluation.

METHODS The separation was performed on an Accucore aQ(2.1 mm×150 mm, 2.6 µm) column with water(A)-acetonitrile(B) gradient elution as the mobile phase by UPLC. The flow rate was 0.2 mL·min⁻¹, the column temperature was 30 ℃, the detection wavelengths were 205, 240 nm.

RESULTS The fingerprint of 10 batches of Jieyu pills was established, 51 common peaks were calibrated at 205 nm and 31 common peaks were calibrated at 240 nm. The similarities were not less than 0.930. Twelve chromatographic peaks including saikosaponin F, saikosaponin A, saikosaponin D, licochalcone A, Z-ligustilide, curcumol, albiflorin, paeoniflorin, liquiritin, rutin, senkyunolide H, and poricoic acid A were identified with reference substances. The results of principal component analysis showed that these 12 components had a strong correlation with Jieyu pills. The content determination method of 12 components was further established. Twelve components showed good linear relationships within their respective concentration ranges(r≥0.9990) with good precision, repeatability, and stability test results. The average recoveries were 98.18%–101.31%, with RSDs of 1.66%–2.87%, the contents were 0.3242–0.5106, 0.7235–1.1311, 0.3884–0.6028, 0.0051–0.0065, 0.6953–0.9856, 0.1975–0.2375, 1.6459–2.1189, 1.8675–2.8654, 0.1336–0.1769, 0.1868–0.2197, 0.2754–0.3065, 0.0254–0.0337 mg·g⁻¹.

CONCLUSION  The method of fingerprint chromatogram and content determination of 12 components established in this study is accurate, stable, and feasible, which can provide a scientific basis for comprehensive control and evaluation of the quality of Jieyu pills.