瑞香素缓释片中瑞香素含量测定方法的建立与验证

摘要

Objective To establish and validate a method for determination of daphnetin in sustained release tablets. Methods The chromatographic column was Agela Venusil C18 (4. 6 mm × 250 mm,5 μm) , and the mobile phase consisted of methanol-0. 05 phosphoric acid(45: 55) at a flow rate of 1. 0 ml/min. The detection wavelength was set at 323 nm with a sample size of 10 JJLI. Results Daphnetin showed good linear relationship at the range of 5-45 μg/ml. The mean recovery was 101. 17% ,and the RSD was 0. 3% . Conclusion The method described in this paper is accurate, specific, and easy to use. So it is suitable for content determination of daphnetin in sustained release tablets.%目的 建立一种测定瑞香素缓释片中瑞香素含量的高效液相色谱法(HPLC)并对其进行验证.方法 色谱柱为Agela Venusil C18(4.6 mm ×250 mm,5 μm),流动相为甲醇-0.05％磷酸溶液(45:55),流速1.0 ml/min,柱温30℃,检测波长323 nm,进样量10μl.结果 瑞香素在5～45 μg/ml范围内具有良好的线性关系,R2=0.9999,平均回收率为101.17％,RSD为0.3％.结论 该法准确可靠,操作简便,可用于瑞香素缓释片的含量测定.