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DiamonsilC18色谱柱(250nmm×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、5.613~28.06nag·L^-1、8.772—43.86mg·L^-1、0.7217~3.608mg·L^-1、1.643~8.215mg·L“和14.60~73.00mg·L“内与峰面积呈良好的线性关系(r≥0.9997),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 develop an RP-HPLC method for simultaneous determination of gallic acid, 5- hydroxylmethyl furfural, morroniside, loganin, sweroside, paeonol and paeoniflorin in Liuwei Dihuang ( tradi- tional Chinese medicine) osmotic pump-controlled release tablets. Methods Isolation of sample was achieved on a Diamonsil C18 column (250 mm ×4. 6 mm,5 i.tm). The column temperature was maintained at 35 ℃ and detection wavelength was set at 254 nm. Solvent A (water,0. 06% phosphoric acid, V: V) and solvent B (acetonitrile,0. 06% phosphoric acid, V: V) were used for gradient elution. The flow rate was 1.0 mL. min-~. Results The linearity ranges of gallic acid,5-hydroxylmethyl furfural, morroniside, loganin, sweroside, paeonol and paeoniflorin were 3. 992- 19. 96 mg·L^-1, 8. 710- 43. 55 mg·L^-1, 5. 613 - 28. 06 mg ·L^-1 , 8. 772 - 43.86 mg·L^-1,0. 721 7-3.608 mg·L^-1, 1. 643- 8. 215 mg .L-t and 14. 60-73.00 mg ·L^-1 ,respectively (r≥0. 999 7). The average recoveries (n =9) of them were 96. 1% ,100. 5% ,99. 1% ,101.1% ,102. 6%, 97.8% and 102. 5% ,respectively. Conclusions The method is simple,rapid and accurate. It can be applied for the quality control of Liuwei Dihuang osmotic pump-controlled release tablets.