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。
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.
出处
《中国药品标准》
CAS
2011年第6期424-427,共4页
Drug Standards of China
