摘要
目的建立HPLC法测定鼻舒适片中马来酸氯苯那敏的含量。方法采用迪马Diamonsil C18柱(200mm×4.6mm,5μm),以乙腈-0.3%十二烷基硫酸钠溶液-磷酸(51∶49∶0.02)(用三乙胺调pH值至4.0)为流动相,柱温为室温,流速1.0ml/min,检测波长260nm。结果马来酸氯苯那敏线性范围是3.5～55.7μg/ml,r=0.9999,平均回收率为104.2%,RSD为2.5%(n=7)。结论HPLC法灵敏、简便、准确,可作为本品质量评价和生产工艺监控的有效方法。
Objective To establish a method for the determination of the content of Chlorphenamine Maleate in the Bishushi tablet by HPLC. Methods Diamonsil C18 column （200 mm×4.6 mm, 5μm） was used at room temperature, the acetonitrile-0.3% sodium dodecyl sulfate solution-phosphoric acid （51：49：0.02） （adjusted pH to 4.0 with triethylamine） was used as mobile phase, the flow rate was 1.0 ml/min, and the determination wavelength was at 260 nm. Results The linear range of Chlorphenamine Maleate was 3.5-55.7μg/ml, r=0.9999, and the average recovery was 104.2%, RSD=2.5% （n=7）. Conclusion This method is simple, rapid, and accurate. It can be used for the control the product quality and its preparation process.
出处
《今日药学》
CAS
2008年第4期11-12,共2页
Pharmacy Today
