【摘要】 目的建立定性测定阿德福韦酯原料及片剂中有关物质阿德福韦单酯的方法。方法分别采用HPLC及液相色谱飞行时间质谱联用法(HPLC-TOF/MS),比较阿德福韦单酯对照品与原料及片剂中相应色谱峰的保留时间、紫外光谱、质谱图、同位素丰度及分子式,定性测定原料及片剂色谱图中的阿德福韦单酯峰。结果阿德福韦酯原料及片剂中有与阿德福韦单酯保留时间一致的色谱峰,被分析物与阿德福韦单酯对照品紫外光谱图、保留时间、质谱图一致,最大吸收波长260 nm;质量精度计算结果显示,被分析物与阿德福韦单酯分子式一致,同位素丰度比与理论值一致。结论该方法能准确、灵敏地定性检测阿德福韦酯原料及片剂中的有关物质阿德福韦单酯。更多还原

【Abstract】 OBJECTIVE To develop a qualitative analylic method for detecting Adefovir monopivoxil in Adefovir dipivoxil drug substance and its tablets.METHODS HPLC-DAD and HPLC-ToF/MS methods were used to compare the retention time,UV,MS of Adefovir monopivoxil reference substance and the corresponding peaks in Adefovir dipivoxil drug substance and its tablets,and exhibit same retention time.The quailty precision and isotopic ratio of the samples were calculated.RESULTS The analyte and reference substance can be separated and the ultraviolet spectra of Adefovir monopivoxil reference substance and samples were consistent between 200-400 nm.And the max absorption wave was 260 nm.The mass chromatograms and isotopic ratio of reference substance and the analyte were uniform.CONCLUSION This method is accurate,sensitive.It is a applicable qualitative method for the detection of the related substance in Adefovir dipivoxil raw materials and tablets.更多还原