摘要
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。
Objective To establish methods for determining the content and content uniformity of chlorpheniramine maleate in Vitamin C Yinqiao Tablets.Methods Kromasil 5-100C18（250mm×4.6mm,5μm）column was used,the mobile phase was acetonitrile-3mL·L-1sodium dodecyl sulfate solution-phosphoric acid（63∶7∶0.02）adjusting pH to 4.0with triethylamine,and the detection wavelength was 262 nm.Results Under the selected chromatography conditions,agood linearity was obtained for chlorpheniramine maleatein in the range of 5.03-100.60μg·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.
出处
《西北药学杂志》
CAS
2017年第3期304-307,共4页
Northwest Pharmaceutical Journal
基金
2012年国家药品标准提高项目
