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[摘要]
目的 建立清眩软胶囊的定性鉴别和定量测定方法。方法 采用TLC法对本方中的川芎、荆芥穗和薄荷进行定性鉴别;采用HPLC法对方中主要成分欧前胡素进行测定。Agilent C18色谱柱(250 mm×4.6 mm,5 μm);以乙腈-水(42.5:57.5)为流动相;检测波长300 nm,柱温为35℃,体积流量为1.5 mL/min。结果 薄层色谱斑点清晰,阴性样品无干扰。欧前胡素在1.09~54.55 μg/mL与峰面积呈良好的线性关系,平均回收率为97.0%,RSD值为0.77%(n=6)。结论 所建立的定性和定量方法结果可靠、准确,重现性好,无干扰,可用于清眩软胶囊的质量控制。
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[Abstract]
Objective To establish the quality control method for Qingxuan Soft Capsule including qualitative identification and quantitative determination. Methods TLC was applied to identifing Chuanxiong Rhizoma, Schizonepetae Spica, and Menthae Haplocalycis Herba. HPLC method was applied to determining imperatorin in Qingxuan Soft Capsule. The analytical column was Agilent C18 (250 mm × 4.6 mm, 5 μm), and the mobile phase was acetonitrile-water (42.5:57.5). The detection wavelength was at 300 nm. The column temperature was at 35℃, and the volume flow was 1.5 mL/min. Results The TLC spots were distinct and reproducible. The linear range of imperatorin was 1.09-54.55 μg/mL. The average recovery rate was 97.0% with RSD 0.77% (n=6). Conclusion The qualitative and quantitative methods established are feasible, accurate, and reproducible, which can be well used for the quality control of Qingxuan Soft Capsule.
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