HPLC-DAD波长切换法测定阿司匹林双嘧达莫片的含量及游离水杨酸  

Determination of two components and salicylic acid in aspirin and dipyridamole tablets by HPLC-DAD wavelength switching method

作　　者：田海燕 刘向国 TIAN Haiyan;LIU Xiangguo(Dezhou Food and Drug Inspection Center,Dezhou 253015,China)

机构地区：[1]德州市食品药品检验检测中心,山东德州253015

出　　处：《中国药品标准》2024年第2期164-167,共4页Drug Standards of China

摘　　要：目的:建立HPLC-DAD波长切换法测定阿司匹林双嘧达莫片的含量及游离水杨酸的方法。方法:采用Agilent ZORBAX SB C 18色谱柱(250 mm×4.6 mm,5μm),以乙腈-四氢呋喃-冰醋酸-水(20∶5∶5∶70)为流动相,流速1.0 mL·min^(-1),柱温30℃,检测波长276 nm(阿司匹林)、284 nm(双嘧达莫)和303 nm(水杨酸)。结果:阿司匹林、双嘧达莫和游离水杨酸分别在38.37~383.71、9.60~96.05和1.02~10.21μg·mL^(-1)范围内线性关系良好。平均回收率分别为99.88%(RSD=0.23%)、99.01%(RSD=0.46%)和100.99%(RSD=0.75%)。本法与标准方法含量测定结果无明显差异。含量均匀度A+2.2S在4.7~6.4。结论:建立的含量测定方法,操作简单,更适用于阿司匹林双嘧达莫片的质量控制。Objective:To establish an HPLC-DAD wavelength-switching method for the determination of aspirin dipyridamole tablets and free salicylic acid.Methods:An Agilent ZORBAX SB C 18 column(250 mm×4.6 mm,5μm)was adopted with acetonitrile-tetrahydrofuran-glacial acetic acid-water(20∶5∶5∶70)as the mobile phase,and isocratic elution was performed at the flow rate of 1.0 mL·min^(-1),the column temperature of 30℃,and the detection wavelengths were 276 nm for aspirin,284 nm for dipyridamole and 303 nm for salicylic acid.Results:Aspirin,dipyridamole and free salicylic acid had a good linear relationship in the range of 38.37-383.71,9.60-96.05 and 1.02-10.21μg·mL^(-1) respectively.The average recoveries were 99.88%(RSD=0.23%),99.01%(RSD=0.46%)and 100.99%(RSD=0.75%),respectively.There was no significant difference for the content resuls between the established method and the standard method.The content uniformity of A+2.2S ranges from 4.7 to 6.4.Conclusion:The established method is simple and suitable for the quality control of aspirin dipyridamole tablets.

关 键 词：阿司匹林 双嘧达莫 游离水杨酸 含量测定 含量均匀度 HPLC-DAD波长切换法 

分 类 号：R921.2[医药卫生—药学]