Research on the simultaneous determination of five active ingredients in Manshanhong Shugan granules by HPLC

Objective: To establish a method for the simultaneous determination of the contents of five components: schaftoside, vincetoxicoside B, isoquercitrin, quercitrin and protocatechuic acid in Manshanhong Shugan granules. Methods: The study employed an Agilent Zorbax SB-Aq-C18 chromatographic column(250 mm×4.6mm, 5 μm), with acetonitrile-0.1% phosphoric acid as the mobile phase, employing gradient elution at a volume flow rate of 0.8 mL/min, a column temperature of 30 ℃, and detection wavelength of 255 nm. Results: Schaftoside, vincetoxicoside B, isoquercitrin, quercitrin and protocatechuic acid exhibited good linear relationships within the concentration ranges of 0.0976 to 1.1712 μg/mL, 0.0833 to 0.9996 μg/mL, 0.0469 to 0.5628 μg/mL, 0.0374 to 0.4488 μg/mL, and 0.0110 to 0.1320 μg/mL, respectively. The active ingredients showed good stability within 24 hours, with good reproducibility. The average sample recovery rates were 100.8%, 100.8%, 101.7%, 101.3%,and 101.1%, respectively. The relative standard deviations(RSD) were 1.1%, 1.0%, 0.7%, 1.1%, and 1.3%, respectively. In six batches of Manshanhong Shugan granules, the content of schaftoside ranged from 0.8869 to 0.9031 mg/g, vincetoxicoside B ranged from 0.1917 to 0.2034 mg/g, isoquercitrin ranged from 0.0827 to 0.1052mg/g, quercitrin ranged from 0.0098 to 0.0140 mg/g, and protocatechuic acid ranged from 0.0655 to 0.0694 mg/g. Conclusion: The established method is simple, accurate, specific and reproducible, establishing an effective and feasible quality control system for Manshanhong Shugan granules.