Simple stability indicating ultraviolet spectroscopic methods for the estimation of ezetimibe in presence of its alkaline degradation product

Author(s): KhalidA.M.Attia,MohamedW.I.Nassar,AhmadAbdelhalimMohamad,AshrafAbdel Fattah

Previously, Gajjar and Shah described the isolation and structure elucidation of major alkaline degradant of Ezetimibe (EZE) using preparative HPLC, [A. K. Gajjar, V.D. Shah. J. Pharm. Biomed. Anal. 55 (2011) 225- 229] based on 1H NMR, 13C NMR and mass spectrometric studies. Then the last paper [Z. Santa, J. Koti, K. Szoke, K. Vukics, C. Szantay. J. Pharm. Biomed. Anal. 58 (2012) 125-129] illustrate that the correct structure of degradant to be (2R,3R,6S)-N,6-bis(4-fluorophenyl)-2-(4- hydroxyphenyl)-3,4,5,6-tetrahydro-2H-pyran-3-carboxamide. 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.

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