反相高效液相色谱法测定阿德福韦酯片的含量  

Content Determination of Adefovir Dipivoxil in Adefovir Dipivoxil Tablets by RP-HPLC

作　　者：马玉蓉[1] 

机构地区：[1]重庆市第五人民医院药剂科,重庆400062

出　　处：《中国药业》2013年第15期51-52,共2页China Pharmaceuticals

摘　　要：目的建立测定阿德福韦酯片中阿德福韦酯含量的反相高效液相色谱(RP-HPLC)法。方法采用Hypersil BDS CPS柱(250 mm×4.6 mm,5μm),以0.02 mol/L磷酸二氢钠溶液(调pH=4.0±0.1)-乙腈(70∶30)为流动相,流速为1.0 mL/min,柱温为30℃,检测波长260 nm。结果阿德福韦酯峰和相邻杂质峰可达到有效分离(R>1.5)。阿德福韦酯进样质量浓度在4.0～80.0μg/mL范围内与峰面积线性关系良好(r=0.999 9,n=5);平均加样回收率分别为99.78%,99.27%,99.67%,RSD分别为0.50%,0.97%,0.78%(n=3);方法精密度和重复性良好(RSD<2%)。结论该方法准确、简便、快速,适用于阿德福韦酯片的质量控制。Objective To establish a RP-HPLC method for determining the content of adefovir dipivoxil in Adefovir Dipivoxil Tablets. Methods THe Hypersil BDS CPS column（250mm×4.6mm,5μm） was adopted with UV detection at 260 nm,and the mo-bile phase consisted of 0. 02 mol/L NaH2PO4 buffer solution（adjusted to pH 4. 0 ±0. 1 with phosphoric acid） -acetonitile （70：30）. The flow rate was 1.0 mL/min and the column temperature was 30 ℃. Results The peak of adefovir dipivoxil was thoroughly separat-ed from its adjacent impurity peaks （R 〉 1.5）. The mass concentration of adefovir dipivoxil sample size within the range of 4. 0-80. 0 μg/mL had a good linear relation with the peak aerea （r =0. 999 9, n =5）. The average recovery rates were 99. 78% ,99. 27% and 99.27% with RSD of 0.50% ,0.97% and 0.78% （ n = 3）,respectively. The methodological reproducibility and precision were good （RSD 〈 2% ）. Conclusion This method is accurate,simple,quick and is suitable for the quality control of Adefovir Dipivoxil Tablets.

关 键 词：高效液相色谱法 阿德福韦酯 含量测定 

分 类 号：R927.2[医药卫生—药学] R978.7