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[摘要]
目的 建立清咽片的质量控制方法。方法 采用薄层色谱法对冰片进行定性鉴别;采用高效液相色谱法对没食子酸进行定量测定。色谱柱为翡纳米公司Kromasil C18柱(250 mm×4.6 mm,5 μm),以乙腈-含0.1%三乙胺的0.1%磷酸水溶液(1∶99)为流动相,体积流量为1 mL/min,检测波长为273 nm。结果 薄层色谱鉴别斑点清晰,阴性样品无干扰;定量测定中没食子酸进样量在0.007 μg~0.035 μg与峰面积线性关系良好(r=0.999 9);平均回收率为98.83%,RSD为1.34%(n=6)。结论 建立的方法操作简单、准确、专属性和重复性好,可用于该制剂的质量控制。
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[Abstract]
Objective To establish the quality standard for Qingyan Tablets. Methods Broneolum Syntheticum was identified by thin-laver chromatography (TLC); Gallic acid was determined by HPLC. The chromatographic separation was achieved on Kromasil C18 column (250 mm×4.6 mm, 5 μm) with acetonitrile-0.1% phosphoric acid (1:99) water solution containing 0.1% triethylamine as mobile phase, the flow rate was 1 mL/min, and the detection wavelength was set at 273 nm. Results TLC spots developed were fairly clear and the blank test showed no interference; The calibration curve was linear within the range of 0.007—0.035 μg (r = 0.999 9); The average recovery rate was 98.83%, and the RSD value was 1.34% (n = 6). Conclusion The established method is accurate and has the advantages of simple operation with strong specificity and reproducibility, and could be used for the quality control of Qingyan Tablets.
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