龟鹿补肾丸HPLC指纹图谱研究

HPLC Fingerprint of Guilubushen Pills

目的:研究并建立龟鹿补肾丸的HPLC指纹图谱。方法:采用反相高效液相色谱法,Dikma Diamonsil C18色谱柱(4.6 mm×250 mm,5μm),以甲醇-水(含0.1%磷酸水溶液)为流动相梯度洗脱,柱温35℃,流速0.8 mL.min-1,检测波长270 nm,进样量20μL,采用对照品比对进行色谱峰指认。结果:方法精密度、稳定性、重复性良好,对34个共有峰中的5个色谱峰进行了定性鉴别,采用该方法测定了10批龟鹿补肾丸,其相似度均>0.968。结论:该研究为龟鹿补肾丸的全面质量评价提供参考。

Objective： To establish HPLC fingerprints of Guilubushen Pills. Method ： High performance liquid chromatography and Dikma Diamonsil Cls column （4.6 mm ×250 mm, 5 μm） was adopted with methanol- water （containing 0.1% phosphoric acid） as the mobile phase in gradient elution form. The column temperature was set at 35℃ , and the flow rate was 0. 8 mL .min-1 The detection wavelength was set at 270 nm. The sample size was 20 μL. Chromatographic peaks were identified by standard substance comparison. Result： Good precision, stability and repeatability were proved. Five standard substances were adopted for qualitative determination of chromatographic peaks during the 34 total common peaks, and their similarities were above0. 968. Conclusion： The study lays a foundation for the overall quality evaluation of Guilubushen Pills.