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知柏地黄丸中盐酸小檗碱和盐酸巴马汀的含量测定

HPLC determination of berberine hydrochloride and palmatine hydrochloride in Zhibai Dihuang pills

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【作者】 陈庆辉唐元军

【Author】 CHEN Qing-hui,TANG Yuan-jun(Fujian Zhangzhou Institute for Drug Control,Zhangzhou 363000,China)

【机构】 福建省漳州市药品检验所

【摘要】 目的:建立知柏地黄丸中盐酸小檗碱和盐酸巴马汀的含量测定,控制知柏地黄丸的质量。方法:采用高效液相色谱法,在Welch Materials XB-C18(5μm,250 mm×4.6 mm)色谱柱上,以乙腈为流动相A,以0.1%三氟乙酸为流动相B,梯度洗脱,检测波长为345 nm,柱温25℃。结果:盐酸小檗碱在3.78~37.8μg.mL-1的浓度范围内具有良好的线性关系,盐酸巴马汀在2.65~26.5μg.mL-1的浓度范围内具有良好的线性关系。盐酸小檗碱和盐酸巴马汀的平均回收率(n=6)分别为97.6%(RSD=1.1%)和99.5%(RSD=0.2%)。结论:用本文方法检验了268批知柏地黄丸样品,发现41批混淆使用了关黄柏。

【Abstract】 Objective:To develop an HPLC method for determination of berberine hydrochloride and palmatine hydrochloride in Zhibai Dihuang pills,so as to provide a reference for the quality control of Zhibai Dihuang pills.Method:The separation was performed on a Welch Materials XB-C18(250 mm×4.6 mm,5 μm) column with the mobile phase consisting of acetonitrile(A) and water containing 0.1% trifluoroacetic acid(B) in gradient elution.The detection wavelength was set at 345 nm,and the column temperature was 25 ℃.Result: The halibration curves were linear within the range of 3.78~37.8 μg·mL-1 for berberine hydrochloride and 2.65~26.50 μg·mL-1 for palmatine hydrochloride.The average recoveries were 97.6%(RSD=1.1%)for berberine hydrochloride and 99.5%(RSD=0.2%)for palmatine hydrochloride.Conclusion::There were 41 batches of samples confused with Phellodendri Amurensis Cortex and Phellodendri Chinensis Cortex in 268 batches of Zhibai Dihuang pills by use of this paper method.

  • 【文献出处】 药物分析杂志 ,Chinese Journal of Pharmaceutical Analysis , 编辑部邮箱 ,2012年12期
  • 【分类号】R286.0
  • 【被引频次】13
  • 【下载频次】392
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