藿香正气不同制剂中苍术素的含量测定

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,5 μm)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0.00095~0.475 μg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 develop an HPLC method for determination of atrctylodin for different preparations of Huoxiangzhengqi. Methods: The analysis was carried out on an Agilent-TC C₁₈(250 mm×4.6 mm,5 μm)column;The mobile phase was composed of acetonitrile(A)and water(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→48% A;31-40 min,48% A)and the flow rate was 1.0 mL·min^-1;The detection wavelength was at 335 nm;The column temperature was 30℃. Result: The linear range of atrctylodin was 0.00095-0.475 μg(r>0.9999) with satisfied precision,repetition,stability and recovery. Conclution: This method is simple,reliable and can be used in quality evaluation of different preparations of Huoxiangzhengqi.

1 ChP(中国药典).2010.Vol Ⅰ(一部):1233
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