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目的:建立当归补血口服液中黄芪甲苷含量的测定方法。方法:色谱条件为Agilent ZORBAXSB-C18柱(4.6mm×250mm,5μm),流动相为乙腈-水(36∶64),流速1.0mL/min,柱温40℃,漂移管温度100℃,载气流量2.7L/min。结果:黄芪甲苷对照品在1.054～15.81μg的范围内,线性关系为Y=1.4356X+5.3832,进样量与峰面积呈良好的线性关系,γ=0.9998,精密度、稳定性及重复性实验均良好,加样回收率实验,平均回收率为100%,RSD%为2.7%。对本品的耐用性实验、阴性对照试验及本品含量测定限度范围进行了考察,选用不同型号,不同规格的色谱柱进行含量测定结果的比较,RSD%为1.3%。结论:该法简便、准确,可用于该制剂中黄芪甲苷的含量测定和质量控制。
Objective: To establish a method for the determination of Astragaloside Ⅳ in Danggui Buxue oral liquid. Methods: The chromatographic conditions were Agilent ZORBAXSB-C18 column (4.6 mm × 250 mm, 5 μm), mobile phase of acetonitrile-water (36:64), flow rate of 1.0 mL / min, column temperature of 40 ℃, drift tube temperature of 100 ℃, Flow 2.7L / min. Results: The standard of Astragaloside was 1.054 ~ 15.81μg, the linear relationship was Y = 1.4356X + 5.3832, and there was a good linear relationship between the injection volume and the peak area, γ = 0.9998, precision, stability and repeatability Experiments were good, the sample recovery experiment, the average recovery was 100%, RSD% of 2.7%. The durability test, the negative control test and the limit of determination of the content of this product were investigated. The comparison of the determination results of different types and different specifications of the chromatographic column showed that the RSD% was 1.3%. Conclusion: The method is simple, accurate and can be used for the determination and quality control of Astragaloside IV in this preparation.