| 引用本文: | 阚微娜,杨宏伟.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[J].中国现代应用药学,2015,32(7):835-838. |
| KAN Weina,YANG Hongwei.Content Determination and Content Uniformity Test of Aminophylline and Chlorphenamine Maleate in Compound Amino-polypeptide Tablets by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(7):835-838. |
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| 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。 |
| 关键词: 复方氨肽素片 氨茶碱 茶碱 马来酸氯苯那敏 高效液相色谱法 |
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| Content Determination and Content Uniformity Test of Aminophylline and Chlorphenamine Maleate in Compound Amino-polypeptide Tablets by HPLC |
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KAN Weina, YANG Hongwei
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Liaoning Institute for Drug Control, Shenyang 110023, China
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| 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. |
| Key words: compound amino-polypeptide tablets aminophylline theophylline chlorphenamine maleate HPLC |
