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目的:测定白银宫血灵胶囊中东莨菪内酯的含量,建立该制剂的质量控制方法。方法:采用高效液相色谱(HPLC)法,使用Kromasil C18柱(4.6 mm×250 mm,5μm);以甲醇-0.5%冰醋酸(40∶60)为流动相;检测波长为345 nm。结果:东莨菪内酯在0.0386~0.7728μg范围内线性关系良好,相关系数为r=0.9999,平均回收率为98.95%,RSD=1.1%。结论:本法简便、快速、重复性好,可作为本品的质量控制方法。
Objective: To determine the content of scopolamine in Baiyin Gong Xue Ling Capsules and establish the quality control method of the preparation. Methods: High performance liquid chromatography (HPLC) was performed on a Kromasil C18 column (4.6 mm × 250 mm, 5 μm) with methanol-0.5% glacial acetic acid (40:60) as the mobile phase. The detection wavelength was 345 nm. Results: Scopolactone had a good linearity in the range of 0.0386 ~ 0.7728 μg with a correlation coefficient of r = 0.9999, with an average recovery of 98.95% and a RSD of 1.1%. Conclusion: This method is simple, rapid, reproducible, and can be used as the quality control method of this product.