目的：建立高效液相色谱法（HPLC）快速测定复方丹参滴丸中丹参素的含量。方法色谱柱为Hypersil C18（4.6 mm×250 mm，5μm）；流动相为甲醇-水-冰醋酸（20∶80∶0.5）,柱温为室温；流速为0.9 mL/min；检测波长为281 nm。结果丹参素对照品在0.01~0.10 mg/mL范围内呈良好线性关系，r=0.9997,含量丹参素平均回收率为99.6%，RSD为0.89%。所测复方丹参滴丸中丹参素的平均含量为8.034 mg/g，符合2010年版药典对其含量的要求。结论 HPLC法测定复方丹参滴丸中丹参素的含量方法操作流程简单、快速、准确，可用于该制剂的质量控制中大力推广使用。%Objective To establish a HPLC method for content determination (HPLC) of Danshensu in Compound Danshen dropping pill.Methods The chromatographic column was Hypersil C18 (4.6 mm×250 mm, 5 μm); the mobile phase of methanol-water-acetic acid (20∶80∶0.5), the column temperature was room temperature; the flow rate was 0.9 mL/min; the detection wavelength was 281 nm.Results Danshensu control sample showed good linear relationship in the range of 0.01-0.10 mg/mLr=0.997, Danshensu content, the average recovery was 99.6%, RSD 0.89%. The average content of pigment compound danshendropping pill for 8.034mg/g, consistent with the 2010 edition of Pharmacopoeia requirements for its content.Conclusion The HPLC method for the determination of content of Danshensu in Compound Danshen Dropping Pill operation is simple, fast, accurate, and can be used for the quality control of the preparation in vigorously promoting the use of.
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