阿司匹林双嘧达莫片中有效成分含量及游离水杨酸限量研究  

Study on the content of active ingredients and limit of free salicylic acid in Aspirin Dipyridamole Tablets

作　　者：巴然然 BA Ran-ran(Tai’an Institute for Food and Drug Control(Tai’an Fiber inspection Institute),Taian 271000,China)

机构地区：[1]泰安市食品药品检验检测研究院(泰安市纤维检验所),山东泰安271000

出　　处：《中国处方药》2022年第6期13-15,共3页Journal of China Prescription Drug

摘　　要：目的 建立同时测定阿司匹林双嘧达莫片中有效成分含量及游离水杨酸限量的方法。方法 采用HPLC法,色谱柱为Waters XBridge C18(250 mm×4.6 mm,5μm),流动相为0.2%磷酸水溶液-乙腈(79∶21),流速1.0 ml/min,检测波长288 nm,柱温30℃。结果 双嘧达莫的线性范围为10~160μg/ml (r=0.999 8),平均回收率为100.59%(n=6);阿司匹林的线性范围为25~400μg/ml(r=0.999 9),平均回收率为99.92%(n=6);水杨酸的线性范围为10~80μg/ml(r=0.999 5),平均回收率为99.69%(n=6)。结论 所建方法简便、准确、可同时测定阿司匹林双嘧达莫片中有效成分含量及游离水杨酸限量。Objective To establish a method for simultaneous determination of active component content and free salicylic acid limit in aspirin dipyridamole tablets.Methods Using HPLC method,The determination was performed on Waters XBridge C18 column(250 mm ×4.6 mm,5 μm) with mobile phase consisted of 0.2% phosphoric acid aqueous solution--acetonitrile(79∶21) at the flow rate of 1.0 ml/min.The detection wavelength was 288 nm,and the column temperature was 30℃.Results The linear range of dipyridamole was 10 ~ 160 μg/ml(r = 0.999 8),and the average recovery was 100.59%(n = 6);The linear range of aspirin was 25 ~ 400 μg/ml(r = 0.999 9),and the average recovery was 99.92%(n = 6).The linear range of salicylic acid was 10 ~ 80 μg/ml(r = 0.999 5),and the average recovery was 99.69%(n = 6).Conclusion The established method is simple,accurate,and can simultaneously determine the content of active components and the limit of free salicylic acid in aspirin dipyridamole tablets.

关 键 词：HPLC 双嘧达莫 阿司匹林 游离水杨酸 

分 类 号：R927.2[医药卫生—药学]