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| HPLC法同时测定扑麻滴鼻液中2成分的含量 |
| Simultaneous Determination of Two Components in Chlorphenamine Maleate and Ephedrine Nasal Drops by HPLC |
| 投稿时间：2014-09-01 修订日期：2015-01-17 |
| DOI： |
| 中文关键词: 扑麻滴鼻液 高效液相色谱法 盐酸麻黄碱 马来酸氯苯那敏 |
| 英文关键词:Chlorphenamine maleate and ephedrine nasal drops HPLC Ephedrine hydrochloride Chlorphenamine maleate |
| 基金项目:军队医疗机构制剂标准提高科研专项重点课题（编号：13ZJZ07） |
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| 中文摘要: |
| 摘 要 目的： 建立同时测定扑麻滴鼻液中盐酸麻黄碱和马来酸氯苯那敏含量的HPLC方法。方法: 采用：Purospher STAR RP18色谱柱（150 mm×4.6 mm，5 μm），以磷酸盐缓冲液(pH3.0±0.1) 乙腈(82∶18)为流动相，流速为1.0 ml·min-1，在210 nm波长处同时检测盐酸麻黄碱和马来酸氯苯那敏，柱温35℃，进样量20 μl。结果:盐酸麻黄碱和马来酸氯苯那敏分别在19.81～118.85 μg·mL-1和6.21～37.25 μg·mL-1浓度范围内线性关系良好，r分别为0.999 6和0.999 8。平均回收率分别为100.39%（RSD=0.69%，n=9）和100.11%（RSD=0.60%，n=9）。结论: 该方法快速简便、重复性、准确性好，可用于该制剂中盐酸麻黄碱和马来酸氯苯那敏的含量测定。 |
| 英文摘要: |
| ABSTRACT Objective: To establish a method for the simultaneous determination of chlorphenamine maleate and ephedrine hydrochloride in chlorphenamine maleate and ephedrine nasal drops by HPLC. Methods: An HPLC method was performed on a column of Purospher STAR RP18（150 mm×4.6 mm，5 μm）with the mobile phase of acetonitrile potassium dihydrogen phosphate buffer (pH 3.0±0.1) (18∶82 v/v) at the detection wavelength of 210 nm (adjusting the flow rate and column temperature to 1.0 ml·min-1 and 35℃, respectively). The injection volume was 20 μl. Results: A good linear relationship was established between the peak response and the concentration of ephedrine hydrochloride and chlorphenamine maleate over the range of 19.81-118.85 μg·mL-1(r=0.999 6) and 6.21-37.25 μg·mL-1(r=0.999 8), respectively. The mean recovery of ephedrine hydrochloride and chlorphenamine maleate was 100.39%（RSD=0.69%，n=9）and 100.11%（RSD=0.60%，n=9）, respectively. Conclusion:The proposed method shows high repeatability, good durability and promising accuracy. It can be employed for the determination of two components in chlorphenamine maleate and ephedrine nasal drops. |
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