Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, El-Messalah, 21521 Alexandria, Egypt.
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, El-Messalah, 21521 Alexandria, Egypt.
Ann Pharm Fr. 2020 Mar;78(2):129-141. doi: 10.1016/j.pharma.2020.01.003. Epub 2020 Jan 23.
Simple and rapid spectrophotometric methods are described for determination of two mixtures of tamsulosin (TM), as minor component, with either solifenacin (SL) or tolterodine (TL). The proposed methods involve treatment of the absorbance ratio spectra or zero order spectra by derivative or discrete Fourier function. TM and TL mixture could not be resolved by manipulation of their zero order spectra due to the strong overlap between both spectra and only derivative or Fourier function coefficients of ratio spectra could resolve their spectra. TM and SL mixture was fully resolved by the manipulation of both ratio and zero order spectra. The values of the derivative or the Fourier function coefficients of ratio spectra and/or zero order spectra, at either peak or trough points, were correlated to the concentration of each drug in each mixture. Calibration graphs were linear in ranges 2.5-40 and 30-500μg.mL using derivative ratio and Fourier function ratio, 5-40 and 80-600μg.mL using direct derivative and 2.5-40 and 30-300μg.mL using direct Fourier function for TM and SL, respectively. The plots of derivative ratio amplitude and the Fourier function ratio coefficient versus concentration were linear over ranges 2.5-20 and 25-250μg.mL for TM and TL, respectively. Higher sensitivity as indicated by lower values of detection and quantitation limits were obtained using Fourier convoluted spectra (ratio or zero order) compared to derivative methods. All validation aspects per ICH guidelines are included. The proposed methods were also applied for the studied drugs assay in their tablets and capsules.
描述了两种简单快速的分光光度法,用于测定他莫昔芬(TM)与索利那新(SL)或托特罗定(TL)的混合物。所提出的方法涉及到通过导数或离散傅里叶函数处理吸光度比光谱或零阶光谱。由于两种光谱之间存在强烈的重叠,因此无法通过操纵它们的零阶光谱来分辨 TM 和 TL 混合物,只有比光谱的导数或傅里叶函数系数才能分辨它们的光谱。TM 和 SL 混合物通过操纵比光谱和零阶光谱都得到了完全分辨。比光谱和/或零阶光谱的导数或傅里叶函数系数在峰或谷点的值与每个混合物中每种药物的浓度相关。使用导数比和傅里叶函数比,在 2.5-40 和 30-500μg.mL 的范围内,使用直接导数在 5-40 和 80-600μg.mL 的范围内,以及使用直接傅里叶函数在 TM 和 SL 中分别在 2.5-40 和 30-300μg.mL 的范围内,校准曲线是线性的。TM 和 TL 的导数比幅度和傅里叶函数比系数与浓度的关系曲线在 2.5-20 和 25-250μg.mL 的范围内是线性的。与导数方法相比,傅里叶卷积光谱(比或零阶)的检测和定量限较低,表明灵敏度更高。包括所有符合 ICH 指南的验证方面。所提出的方法还应用于研究药物在片剂和胶囊中的测定。