HPLC法测定阿德福韦酯口腔崩解片中阿德福韦酯降解产物的含量

Determination of Adefovir Monopivoxil and PMEA in Adefovir Dipivoxil Orally Disintegrating Tablets by HPLC

目的:建立HPLC法测定阿德福韦酯口腔崩解片中降解产物阿德福韦单特戊酸甲基酯(阿德福韦单酯)与9-(2-膦酰甲氧乙基)腺嘌呤(PMEA)的方法。方法:采用Thermo氨基柱Aps-2 HYPERSIL(250 mm×4.6 mm,5μm);流动相为磷酸盐缓冲液-乙腈(30:70):流速1.0 ml·min^(-1);检测波长260 nm;枉温为30℃。结果:阿德福韦单酯在0.10～10.08μg·ml^(-1)范围内线性关系良好,r=0.999 6,平均回收率为101.0%,RSD为0.53%(n=9);PMEA在0.10～10.11μg·ml^(-1)范围内线性关系良好,r=0.999 5,平均回收率为100.7%,RSD为1.85%(n=9)。结论:该方法能同时测定阿德福韦酯降解产物阿德福韦单酯和PMEA,可用于阿德福韦酯降解产物的定量检测。

Objective：To establish an HPLC method for the determination of adefovir monopivoxil and PMEA in adefovir dipivoxil oially disintegrating tablets.Method：An Hvpersil amid-column（250 min×4.6 mm,5μm） was used with phosphate buffer-acetonitrile （30-70） as the mobile phase at a flow rate of 1.0 ml ？ min^（-1）.The detection wavelength was 260 nm and the column temperature was 301;.Result：The calibration curves were linear（r= 0.999 6 and 0.999 5） within the range of 0.10 ~ 10.08μg ？ ml^（-1） and 0.10 ~ 10.11μg ？ ml^（-1） for adefovir monopivoxil and PMEA,respectively.The average recovery of adefovir monopivoxil and PMKA was 101.0%（RSD=0.53%,n=9） and 100.7%（RSI） = 1.85%,n =9）,respectively.Conclusion：The method is simple and reproducible,and can be applied in the simultaneous determination of adefovir monopivoxil and PMEA.