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| 马来酸氯苯那敏片及注射液含量测定方法的探讨 |
| Study on Content Determination of Chlorphenamine Maleate Tablets and Injections |
| 投稿时间：2014-08-11 修订日期：2014-12-17 |
| DOI： |
| 中文关键词: 马来酸氯苯那敏片 马来酸氯苯那敏注射液 含量测定 |
| 英文关键词:Chlorphenamine maleate tablets Chlorphenamine maleate injections Determination |
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| 中文摘要: |
| 摘 要 目的： 统一《中国药典》中马来酸氯苯那敏片与注射液含量测定的方法。方法: 色谱条件：色谱柱Inertsil C8柱（150 mm×4.6 mm，5 μm）；流动相：以磷酸盐缓冲液（取磷酸二氢铵11.5 g,加水适量使溶解，加磷酸1 ml,用水稀释至1 000 ml） 乙腈（70∶30）为流动相；流速为1.0 ml·min-1；柱温：室温 ；进样量：10 μl；检测波长262 nm。结果:氯苯那敏在0.017 8～0.445 0 mg·mL-1范围内呈良好线性关系（r=0.999 9）。平均回收率：片剂为100.2%（RSD=0.4%，n=9），注射液为100.3%（RSD=0.9%，n=9)。结论: 此法操作简单，重复性好，结果准确，为统一马来酸氯苯那敏片、注射液及滴丸的含量测定提供参考。 |
| 英文摘要: |
| ABSTRACT Objective: To unify the content determination method for chlorphenamine maleate tablets and injections. Methods: An Inertsil C 8(150 mm×4.6 mm, 5 μm) column was used, the mobile phase was phosphate buffer (ammonium phosphate monobasic 11.5g was dissolved in water, 1 ml phosphoric acid was added and diluted to 1 000 ml by water) acetonitrile (70∶30), the flow rate was 1.0 ml·min-1, the column temperature was room temperature, the sample volume was 10 μl and the detection wavelength was 262 nm.Results: The linear range of chlorpheniramine was 0.017 8=0.445 0 mg·mL-1(r=0.999 9); the average recovery of the tablets and injections was 100.2%（RSD=0.4%，n=9）and 100.3%（RSD=0.9%，n=9), respectively. Conclusion:The method is simple, reproducible and accurate, and can provide reliable basis for the standards of chlorpheniramine maleate tablets, injections and dropping pills. |
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