HPLC法测定香砂养胃片中4种有效成分的含量

目的: 利用高效液相色谱梯度洗脱法同时测定香砂养胃片中木香烃内酯、去氢木香烃内酯、和厚朴酚及厚朴酚4种活性成分的含量。方法: 采用Agilent XDB-C₁₈色谱柱(4.6 mm(]·min^-1流速梯度洗脱,检测波长225 nm。结果: 木香烃内酯、去氢木香烃内酯、和厚朴酚及厚朴酚4种成分线性范围分别为1.960~24.50 μg·mL^-1(r=0.999 0)、2.016~25.20 μg·mL^-1(r=0.999 3)、9.740~121.8 μg·mL^-1(r=0.999 9)和10.84~135.5 μg·mL^-1(r=0.999 8),加样回收率(n=6)分别为101.2%、98.48%、100.5%和99.66%,重复性试验含量的RSD(n=6)分别为1.7%、1.2%、0.7%和1.1%;样品测定结果(n=3):木香烃内酯0.400~1.463 mg·片^-1,去氢木香烃内酯0.512~0.983 mg·片^-1,和厚朴酚1.773~2.027 mg·片^-1,厚朴酚0.950~1.151 mg·片^-1。结论: 所建立的方法操作简单,结果准确,重复性好,可有效地控制该制剂的内在质量,也为提高该药品质量标准提供一个参考方法。

Objective: To establish an HPLC gradient elution method for simultaneous determination of costunolide,dehydrocostuslactone,honokiol and magnolol in Xiangsha Yangwei tablets. Methods: The quantitative analysis was carried out on an Agilent XDB-C₁₈ column(4.6 mm×250 mm,5 μm) with a gradient elution using methanol(A) and water(B) as mobile phase at a flow rate of 1.0 mL·min^-1.The column temperature was controlled at 35℃.The elute was detected at a wavelength of 225 nm. Results: The linear ranges of costunolide,dehydrocostuslactone,honokiol and magnolol were 1.960-24.50 μg·mL^-1(r=0.999 0),2.016-25.20 μg·mL^-1(r=0.999 3),9.740-121.8μg·mL^-1(r=0.999 9) and 10.84-135.5 μg·mL^-1 (r=0.999 8),respectively;the average recoveries(n=6) were 101.2%,98.48%,100.5% and 99.66%,respectively;in repetitiveness(n=6)the RSDs were 1.7%,1.2%,0.7% and 1.1%,respectively.In different batch number of samples,the determination results(n=3) of costunolide,dehydrocostuslactone,honokiol and magnolol were in the ranges of 0.400-1.463 mg per tablet,0.512-0.983 mg per tablet,1.773-2.027 mg per tablet and 0.950-1.151 mg per tablet,respectively. Conclusion: This method is simple,accurate,and reliable,which can be applied to control inner quality efficiently.In addition,this study also provides a reference standard for the quality control of Xiangsha Yangwei tablets.