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目的建立RP-HPLC法同时测定六味地黄渗透泵片中没食子酸、5-羟甲基糠醛、莫诺苷、马钱苷、獐芽菜苷、芍药苷和丹皮酚7种活性成分的含量。方法采用Diamonsil C18色谱柱(250mm×4.6mm,5μm),以体积分数为0.06%磷酸乙腈溶液(A)和体积分数为0.06%磷酸水溶液(B)为流动相,梯度洗脱,流速为1.0mL·min-1,检测波长为254nm,柱温为35℃。结果没食子酸、5-羟甲基糠醛、莫诺苷、马钱苷、獐芽菜苷、芍药苷和丹皮酚质量浓度分别在3.992~19.96mg·L-1、8.710~43.55mg·L-1、5.613~28.06mg·L-1、8.772~43.86mg·L-1、0.721 7~3.608mg·L-1、1.643~8.215mg·L-1和14.60~73.00mg·L-1内与峰面积呈良好的线性关系(r≥0.999 7),平均回收率(n=9)分别为96.1%、100.5%、99.1%、101.1%、102.6%、97.8%和102.5%。结论本方法快速简便,具有较好的重复性和稳定性,为六味地黄渗透泵片的质量控制提供参考。
OBJECTIVE To establish an RP-HPLC method for the simultaneous determination of seven active ingredients including gallic acid, 5-hydroxymethylfurfural, morroniside, loganin, mesogenin, paeoniflorin and paeonol in Liuwei Dihuang osmotic pump tablets. Methods Diamonsil C18 column (250 mm × 4.6 mm, 5 μm) was used as the mobile phase with a mobile phase of 0.06% phosphoric acid (A) and 0.06% phosphoric acid (B) Min-1, the detection wavelength was 254nm, the column temperature was 35 ℃. Results The concentrations of gallic acid, 5-hydroxymethylfurfural, morroniside, loganin, mesogenin, paeoniflorin and paeonol were between 3.992 and 19.96 mg · L-1, and between 1.87 and 43.55 mg · L- 1,5.613 to 28.06 mg · L-1,8.772 to 43.86 mg · L-1, 0.721 7 to 3.608 mg · L -1, 1.693 to 8.215 mg · L -1 and 14.60 to 73.00 mg · L -1 (R≥0.9997), and the average recoveries (n = 9) were 96.1%, 100.5%, 99.1%, 101.1%, 102.6%, 97.8% and 102.5%, respectively. Conclusion The method is rapid and simple, has good repeatability and stability, and provides reference for the quality control of Liuwei Dihuang osmotic pump tablets.