A facile method is proposed herein for simultaneous quantification of ezetemibe, atorvastatin and simvastatin in their commercial tablets. In this study FTIR procedure is described for the simultaneous quantitative determination of two commercial tablet dosage forms composed of (ezetemibe – atorvastatin) and (ezetemibe – simvastatin). For the developed FTIR spectroscopic method, potassium bromide (KBr) disc technique had been used. Specific absorption bands at 514, 1651 and 868 cm⁻¹ were chosen for selective simultaneous analysis of ezetemibe, atorvastatin and simvastatin respectively. In this method, beer’s law was obeyed in the concentration ranges 0.06 –0.40 and 0.12 – 0.30 % w/w in KBr disc for the investigated drugs alone and at their synthetic binary mixtures respectively. Validation study was performed using USP XXV validation and International Conference on Harmonization (ICH) guidelines and resulted in good recoveries ranged from 87.24 to 104.24 % with relative standard deviations less than 8.00 % depicting accuracy, precision, robustness and ruggedness of the developed method. Excellent recoveries were obtained upon application of the developed method to their commercial binary tablets ranged from 92.00 to 100.54 % conforming the suitability of the proposed method for routine analysis at the quality control laboratories.

本文提出了一种简便的方法，用于同时定量测定市售片剂中的依折麦布、阿托伐他汀和辛伐他汀。在本研究中，FTIR 程序描述了同时定量测定由（依折麦布 – 阿托伐他汀）和（依折麦布 – 辛伐他汀）组成的两种商业片剂剂型。对于开发的 FTIR 光谱方法，使用了溴化钾 (KBr) 圆盘技术。514、1651 和 868 cm ^-1处的特定吸收带分别用于选择性同时分析依折麦布、阿托伐他汀和辛伐他汀。在该方法中，对于单独研究的药物和它们合成的二元混合物，在 KBr 盘中浓度范围为 0.06 – 0.40 和 0.12 – 0.30 % w/w 的范围内遵守啤酒定律。验证研究是使用 USP XXV 验证和国际协调会议 (ICH) 指南进行的，结果良好的回收率范围为 87.24 至 104.24 %，相对标准偏差小于 8.00 %，表明所开发方法的准确度、精密度、稳健性和耐用性。将开发的方法应用于其商业二元片剂后获得了极好的回收率，范围为 92.00 到 100。