维C银翘片中马来酸氯苯那敏均匀度检查及其含量检测方法的改进

目的建立维C银翘片中马来酸氯苯那敏的含量及含量均匀度测定方法。方法采用HPLC法,Kromasil 5-100C_(18)(250mm×4.6mm,5μm)色谱柱;以乙腈-3mL·L~(-1)十二烷基硫酸钠溶液-磷酸(63∶37∶0.02)为流动相,用三乙胺调节pH值到4.0;检测波长为262nm。结果在选定的色谱条件下,马来酸氯苯那敏质量浓度在5.03~100.60μg·mL~(-1)范围内线性关系良好(r=0.999 9),回收率为102.7%,RSD值为1.6%(n=9),重复性RSD值为0.7%(n=9)。结论该方法简便、准确,可用于该制剂的质量控制。

Improvement of the content determination and content uniformity methods of chlorpheniramine maleate in Vitamin C Yinqiao Tablets

Objective To establish methods for determining the content and content uniformity of chlorpheniramine maleate in Vitamin C Yinqiao Tablets.Methods Kromasil 5-100 C18(250 mm×4.6 mm,5 μm)column was used,the mobile phase was acetonitrile-3 mL·L-1sodium dodecyl sulfate solution-phosphoric acid (63∶7∶0.02) adjusting pH to 4.0 with triethylamine,and the detection wavelength was 262 nm.Results Under the selected chromatography conditions,a good linearity was obtained for chlorpheniramine maleatein in the range of 5.03-100.60 μg·mL-1,r=0.999 9.The average recovery was 102.7% with RSD was 1.6%(n=9).The repeatability RSD was 0.7%(n=9).Conclusion The method is accurate,and can be used to the quality control of the preparation.