摘要
目的：研究速感宁片中马来酸氯苯那敏定性定量分析方法。方法：采用薄层色谱法对马来酸氯苯那敏进行定性鉴别;采用高效液相色谱法对马来酸氯苯那敏进行含量测定,色谱柱为Shimpack CLC-ODS色谱柱（150mm×6.0mm,5μm）,流动相为乙腈-0.3%十二烷基硫酸钠-磷酸（60：40：0.02）（用三乙胺调pH至3.3±0.1）,流速1.0mL.min-1,柱温为室温,检测波长262nm。结果：薄层色谱图斑点清晰,阴性对照无干扰;高效液相色谱法测得马来酸氯苯那敏进样量在0.0852～0.7668μg范围内线性关系良好,r=0.9999;平均加样回收率为99.5%,RSD=0.63%（n=6）。结论：该方法简便,专属性强,重复性好,可作为速感宁片中马来酸氯苯那敏质量控制方法。
Objective：To study the methods of qualitation and quantitation of chlorphenamine maleate in Suganning tablets.Method：TLC was used for chlorphenamine maleate.chlorphenamine was determined by HPLC,shim-pack CLC-ODS column （6.0 mm×150 mm,5 μm） was adopted and the mobile phase was acetonitrile 0.3% sodium laurylsulffate phosphoric acid（60：40：0.02）（adjusting pH to 3.3±0.1 with triethylamine） at the flow rate of 1.0 mL·min-1,The column temperature was at room temperature and the detection wavelength was 262 nm.Results：The dot of TLC was clear and the negative comparison with no disturbance.chlorphenamine maleate show a good linear relationship in the range of 0.0852-0.7668 μg,r =0.9999,and the average recovery was 99.5% with RSD 0.63%（n=6）.Conclusion：The method is simple,vspecific,and accurate with good reproducibility.It can be used for quality control of chlorphenamine maleate in Suganning tablets.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2010年第10期1969-1971,共3页
Chinese Journal of Pharmaceutical Analysis
