摘要

在其碱性降解产物存在的情况下，用简单的稳定性指示紫外光谱法估计依折麦布的含量

作者(年代):KhalidA.M.Attia MohamedW.I。Nassar AhmadAbdelhalimMohamad AshrafAbdel Fattah

在此之前，Gajjar和Shah使用制备高效液相色谱法描述了Ezetimibe (EZE)主要碱性降解物的分离和结构阐明，[A。K. Gajjar, V.D. Shah。j .制药。生物医学。肛55(2011)225- 229]基于1H NMR, 13C NMR和质谱研究。最后一篇论文[Z。Santa, J. Koti, K. Szoke, K. Vukics, C. Szantay。j .制药。生物医学。Anal. 58(2012) 125-129]表明降解剂的正确结构为(2R,3R,6S)- n,6-双(4-氟苯基)-2-(4-羟基苯基)-3,4,5,6-四氢- 2h -吡喃-3-羧酰胺。 This work describe three simple, specific and accurate spectrophotometric which developed and validated for determination of ezetimibe (EZE) in presence of its alkaline degradation product without previous separation, namely (Ratio subtraction; amplitude modulation; simultaneous equation), calibration graphs were established in the range of 2-20ug/mL with good correlation coefficients. The developed methods have been successfully applied for the simultaneous analysis of ezetimbe (EZE) in its pharmaceutical dosage form. The methods were validated as per ICH guidelines; accuracy, precision and repeatability were found to be within the acceptable limit.