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目的同时测定梓葛冻干粉针中梓醇和葛根素含量并考察其有关物质,为梓葛冻干粉针质量标准的制定提供参考。方法采用RP-HPLC,色谱条件如下,色谱柱:Agilent Zorbax SB-C18(4.6 mm×250 mm,5μm),流动相:水(A)-乙腈(B),梯度洗脱,检测波长:210 nm,流速:1.0 mL.min-1。结果该色谱条件下,空白辅料对主药测定无干扰,药物峰与各有关物质峰分离良好。梓醇和葛根素均在5～200 mg.L-1内线性关系良好,平均加样回收率分别为100.45%和98.17%,精密度、重复性RSD均小于2%。结论本方法专属性强,准确、灵敏、简单,可用于梓葛冻干粉针剂的含量测定和有关物质的检查。
OBJECTIVE To determine the content of catalpol and puerarin in Zige freeze-dried powder injection and to investigate the related substances, and provide a reference for the development of Zige freeze-dried powder quality standard. Methods The chromatographic conditions were as follows: Agilent Zorbax SB-C18 (4.6 mm × 250 mm, 5 μm), mobile phase: water (A) -acetonitrile, gradient elution, detection wavelength: 210 nm , Flow rate: 1.0 mL.min-1. Results Under the chromatographic conditions, the blank adjuvant did not interfere with the determination of the main drug, and the drug peak was well separated from the peaks of related substances. Both catalpol and puerarin had a good linearity within the range of 5 ~ 200 mg.L-1. The average recoveries were 100.45% and 98.17%, respectively. The precision and repeatability of RSD were less than 2%. Conclusion This method is specific, accurate, sensitive and simple. It can be used to determine the content of Zi Ge freeze-dried powder injection and related substances.