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| HPLC法测定维C银翘片中马来酸氯苯那敏的含量及含量均匀度 | |
| 引用本文： | 魏丽萍,吴春敏. HPLC法测定维C银翘片中马来酸氯苯那敏的含量及含量均匀度[J]. 中国药品标准, 2011, 12(6): 424-427 |
| 作者姓名： | 魏丽萍 吴春敏 |
| 作者单位： | 1. 福建省药品检验所,福州350001;福建中医学院药学系,福州350003 2. 福建省药品检验所,福州,350001 |
| 摘 要： | 目的:建立HPLC法测定维C银翘片中马来酸氯苯那敏的含量及含量均匀度.方法:采用Phenomenex Prodigy ODS3柱(4.6 mm×250 mm,5μm),以乙腈-0.5％十二烷基硫酸钠-磷酸溶液(60∶40∶0.05)为流动相,流速1.0 mL·min-1,检测波长263 nm.结果:马来酸氯苯那敏在4.1824 ～209.120 0μg·mL-1范围内呈良好线性关系(r=1.000)；平均回收率(n=3)为96.69％～101.10％(RSD为1.22％～2.95％).结论:该方法简便、可靠、准确,可用于该制剂的质量控制. |
| 关 键 词： | 维C银翘片 马来酸氯苯那敏 含量均匀度 高效液相色谱法 |
Determination of Content and its Uniformity of Chlorphenamine Maleate in Vitamin C Yin-qiao Tablets by HPLC |
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| Wei Li-ping and Wu Chun-min. Determination of Content and its Uniformity of Chlorphenamine Maleate in Vitamin C Yin-qiao Tablets by HPLC[J]. , 2011, 12(6): 424-427 | |
| Authors: | Wei Li-ping and Wu Chun-min |
| Affiliation: | 2 ( 1. Fujian Institute for Drug Control, Fuzhou 350001 ; 2. Fujian College of Traditional Chinese Medicine, Fuzhou 350003 ) |
| Abstract: | Objective ： To establish an HPLC method for determination of content and its uniformity of chlorphenamine maleate in Vita- min C Yinqiao Tablets. Methods： The analysis was achieved on a Phenomenex Prodigy ODS3 column（4. 6 mm×250 mm,5 μm）using a mobile phase of Acetonitrile-0. 5% Sodium dodecyl sulfate-Phosphoric acid （60： 40： 0. 05 ）. The flow rate was 1.0 mL ·rain-J, and the detection wavelength was 263 nm. Results： The linear range of chlorphenamine maleate was 4. 182 4 - 209. 120 0 μg ·mL-1 （ r = 1. 000） ,and the average recoveries （n = 3） were 96. 69% - 101.10% with RSD1.22% -2. 95%. Conclusion： The method is sim- ple, reliable, accurate and can be applied to the quality control of the preparation. |
| Keywords: | Vitamin C Yinqiao Tablets Chlorphenamine maleate Content uniformity HPLC |
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