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高效液相色谱法测定鼻炎康片中麻黄碱和伪麻黄碱的含量
引用本文:张俐,王玉.高效液相色谱法测定鼻炎康片中麻黄碱和伪麻黄碱的含量[J].中南药学,2013(10):761-764.
作者姓名:张俐  王玉
作者单位:江苏省食品药品检验所,南京210008
摘    要:目的建立高效液相色谱法测定鼻炎康片中盐酸麻黄碱和盐酸伪麻黄碱的含量。方法采用高效液相色谱法,色谱柱:Phenomenex C18(250mm×4.6mm,5μm);流动相:甲醇-0.07mol·L^-1磷酸钠溶液(用磷酸调pH=6.0,含17.5mmol十二烷基硫酸钠)(50:50);检测波长:210nm。结果盐酸麻黄碱进样量在0.01029~1.029μg呈现良好的线性关系,r=0.9999;盐酸伪麻黄碱进样量在0.02023~0.5058μg呈现良好的线性关系,r=0.9997。盐酸麻黄碱平均加样回收率为95.6%(n=6),RSD为1.6%;盐酸伪麻黄碱平均加样回收率为97.9%(n=6),RSD为1.6%。结论本法准确、重复性好,可有效控制制剂中盐酸麻黄碱、盐酸伪麻黄碱的含量。

关 键 词:盐酸麻黄碱  盐酸伪麻黄碱  鼻炎康片  高效液相色谱法

Content determination of ephedrine and pseudoephedrine in Biyankang tablets by HPLC
ZHANG Li,WANG Yu.Content determination of ephedrine and pseudoephedrine in Biyankang tablets by HPLC[J].Central South Pharmacy,2013(10):761-764.
Authors:ZHANG Li  WANG Yu
Institution:(Jiangsu Institute for Food and Drug Control, Nanjing 210008)
Abstract:Objective To establish a method for the content determination of ephedrine and pseudoephedrine in Biyankang tablets by HPLC. Methods HPLC method was adopted. The separation was performed on Phenomenex C18 (250mm×4.6mm,5μm) column with the mobile phase of methanol-0.07mol·L^-1 Na3PO4 solution (pH adjusted to 6.0 by H3PO4, including 17.5 mmol C12H2sOSO3Na) (50 : 50). The detection wavelength was 210 nm. Results The linear range of ephedrine was 0.010 29 - 1.029 μg (r = 0.999 9). The average recovery (n = 6) was 95.6% (RSD = 1.6%). The linear range of pseudoephedrine was 0.020 23 -- 0.505 8 μg (r = 0.999 7). The average recovery (n = 6) was 97.9% (RSD = 1.6%). Conclusion The method is accurate and reproducible for the content determination of ephedrine and pseudoephedrine in Biyankang tablets. The study may provide a scientific basis for the quality control of Biyankang tablets.
Keywords:ephedrine  pseudoephedrine  Biyankang tablet  HPLC
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