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目的:建立藿香正气片、口服液和软胶囊中苍术素的含量测定方法。方法:采用高效液相色谱法,使用Agilent TC-C18(250 mm×4.6 mm,5μm)色谱柱,以乙腈为流动相A,水为流动相B,进行梯度洗脱(0～8 min,48%A;8～9 min,48%A～64%A;9～16 min,64%A;16～17 min,64%A～75%A;17～30 min,75%A;30～31 min,75%A～48%A;31～40 min,48%A);流速1.0 mL.min-1;检测波长为335 nm。结果:苍术素的质量浓度在0.00095～0.475μg范围内与峰面积线性关系良好,r=0.9999;精密度、重复性、稳定性及加样回收率结果均能满足分析要求。结论:该方法准确可行,为评价藿香正气药品的质量提供可靠的依据。
OBJECTIVE: To establish a method for determination of the contents of atractylodes macrocephala in Huoxiangzhengqi Tablets, oral liquid and soft capsule. METHODS: HPLC was performed on a Agilent TC-C18 (250 mm × 4.6 mm, 5 μm) column using acetonitrile as mobile phase A and water as mobile phase B with gradient elution (0-8 min, 48 % A; 8-9 min 48% A 64% A 9-16 min 64% A 16-17 min 64% A 75% A 17-30 min 75% A 30-31 min, 75% A to 48% A; 31 to 40 min, 48% A); the flow rate was 1.0 mL.min-1; the detection wavelength was 335 nm. Results: The results showed that the concentration of atractylenol was linear with the peak area in the range of 0.00095-0.475 μg, r = 0.9999. The results of precision, repeatability, stability and sample recovery all could meet the analytical requirements. Conclusion: This method is accurate and feasible, and provides a reliable basis for evaluating the quality of Huoxiangzhengqi drug.