愈风宁心片HPLC特征图谱研究

目的: 建立愈风宁心片的特征图谱,提高其质量控制水平。 方法: 以葛根素为参照峰,采用CAPCELL PAK^® MG Ⅱ、Agilent^® ZORBAX SB 或Kromasil^®100-5 C₁₈色谱柱,以甲醇(A)-水(B)为流动相,进行梯度洗脱(0~35 min,15%~30%A;35~60 min,30%~90%A);流速1.0 mL·min^-1;检测波长:250 nm。 结果: 愈风宁心片特征图谱有9个共有峰,方法学考察结果良好,该方法已推广至系列品种。 结论: 采用HPLC特征图谱可实现全面和整体的评价,为有效提高愈风宁心片质量控制水平提供依据。

Objective: To establish an HPLC specific chromatogram of Yufeng Ningxin tablets so as to improve the quality control capacity. Methods: Eleven samples of Yufeng Ningxin Tablet from 4 different manufacturers were determined by HPLC method on a CAPCELL PAK^® MG II, Agilent^® R ZORBAX SB or Kromasil^® 100-5 C₁₈ column (250 mm × 4.6 mm, 5μm) under the chromatographic conditions with methanol (A)-water (B) as a gradient elution (0-35 min, 15%→30%A; 35-60 min, 30%→90%A) at a flow rate of 1.0 mL·min^-1 and 250 nm as a detection wavelength. Results: The HPLC specific chromatogram of Yufeng Ningxin tablets showed 9 common peaks. Based on the methodological validation results, the developed method was good and has been applied to series varieties for the determination of analytes. Conclusion: The specific chromatogram by HPLC can realize the comprehensive and overall assessment, and provide a basis for improving the quality control of Yufeng Ningxin tablets.

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