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    HPLC测定复方氨肽素片中氨茶碱与马来酸氯苯那敏的含量及含量均匀度

    Content Determination and Content Uniformity Test of Aminophylline and Chlorphenamine Maleate in Compound Amino-polypeptide Tablets by HPLC

      摘要
    • 摘要: 目的 建立HPLC测定复方氨肽素片中氨茶碱与马来酸氯苯那敏的含量及含量均匀度。方法 色谱柱为YMC Hydrosphere C18(4.6 mm×250 mm，5 μm)，流动相为乙腈-0.5%磷酸溶液(用三乙胺调pH值至2.2)(10∶90)，流速为1.0 mL·min-1，柱温为30 ℃，检测波长为262 nm。结果 茶碱和马来酸氯苯那敏分别在0.06~0.58 mg·mL-1和2.2~20.0 μg·mL-1内线性关系良好，回收率分别为100.4%和101.2%，RSD分别为0.74%和1.40%(n=9)。结论 方法快速准确，重复性好，结果可靠，可同时测定氨茶碱及马来酸氯苯那敏，为产品质量标准提高提供基础。

       

      Abstract: OBJECTIVE To establish a method for the content and content uniformity of aminophylline and chlorphenamine maleate in compound amino-polypeptide tablets by HPLC. METHODS The YMC Hydrosphere C18 column (4.6 mm×250 mm, 5 μm) was used with the mobile phase of acetonitrile-0.5% H3PO4(adjust pH to 2.2 by triehtylamine)(10∶90). The flow rate was 1.0 mL·min-1. The column temperature was 30 ℃. The wavelength was 262 nm. RESULTS The calibration curves of aminophylline and chlorphenamine maleate were 0.06-0.58 mg·mL-1 and 2.2-20.0 μg·mL-1 respectively. Their recoveries were 100.4% and 101.2%, with RSDs of 0.74% and 1.40% (n=9), respectively. CONCLUSION The method is rapid, accurate and high efficiency to determinate aminophylline and chlorphenamine maleate simultaneously, so as to provide the basis for product quality standards.

       

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