Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
Faculty of Pharmaceutical Science and Pharmaceutical Industries, Future University in Egypt, End of 90th St., Fifth Settlement, New Cairo, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2018 Sep 5;202:131-145. doi: 10.1016/j.saa.2018.04.046. Epub 2018 Apr 24.
Five simple, rapid, accurate, and precise spectrophotometric methods are developed for the determination of Silodosin (SLD) in the presence of its acid induced and oxidative induced degradation products. Method A is based on dual wavelength (DW) method; two wavelengths are selected at which the absorbance of the oxidative induced degradation product is the same, so wavelengths 352 and 377 nm are used to determine SLD in the presence of its oxidative induced degradation product. Method B depends on induced dual wavelength theory (IDW), which is based on selecting two wavelengths on the zero-order spectrum of SLD where the difference in absorbance between them for the spectrum of acid induced degradation products is not equal to zero so through multiplying by the equality factor, the absorption difference is made to be zero for the acid induced degradation product while it is still significant for SLD. Method C is first derivative (D) spectrophotometry of SLD and its degradation products. Peak amplitudes are measured at 317 and 357 nm. Method D is ratio difference spectrophotometry (RD) where the drug is determined by the difference in amplitude between two selected wavelengths, at 350 and 277 nm for the ratio spectrum of SLD and its acid induced degradation products while for the ratio spectrum of SLD and its oxidative induced degradation products the difference in amplitude is measured at 345 and 292 nm. Method E depends on measuring peak amplitudes of the first derivative of the ratio (DD) where peak amplitudes are measured at 330 nm in the presence of the acid induced degradation product and measured by peak to peak technique at 326 and 369 nm in the presence of the oxidative induced degradation product. The proposed methods are validated according to ICH recommendations. The calibration curves for all the proposed methods are linear over a concentration range of 5-70 μg/mL. The selectivity of the proposed methods was tested using different laboratory prepared mixtures of SLD with either its acid induced or oxidative induced degradation products showing specificity of SLD with accepted recovery values. The proposed methods have been successfully applied to the analysis of SLD in pharmaceutical dosage forms without interference from additives.
五种简单、快速、准确和精确的分光光度法被开发出来，用于在酸诱导和氧化诱导降解产物存在下测定西洛多辛（SLD）的含量。方法 A 基于双波长（DW）法；选择两个波长，使氧化诱导降解产物的吸光度相同，因此在 352nm 和 377nm 处使用波长来测定 SLD 在其氧化诱导降解产物存在下的含量。方法 B 依赖于诱导双波长理论（IDW），该理论基于在 SLD 的零阶光谱上选择两个波长，在这些波长处，它们之间的吸光度差异对于酸诱导降解产物的光谱不为零，因此通过乘以相等因子，使吸光度差异对于酸诱导降解产物为零，而对于 SLD 仍然显著。方法 C 是 SLD 及其降解产物的一阶导数（D）分光光度法。在 317nm 和 357nm 处测量峰振幅。方法 D 是比率差分光光度法（RD），通过在两个选定波长处测量振幅差来测定药物，对于 SLD 及其酸诱导降解产物的比率光谱，在 350nm 和 277nm 处测量，而对于 SLD 及其氧化诱导降解产物的比率光谱，在 345nm 和 292nm 处测量振幅差。方法 E 依赖于测量比率的一阶导数的峰振幅（DD），在酸诱导降解产物存在下，在 330nm 处测量峰振幅，在氧化诱导降解产物存在下，通过峰到峰技术在 326nm 和 369nm 处测量峰振幅。所提出的方法根据 ICH 建议进行了验证。所有提出的方法的校准曲线在 5-70μg/mL 的浓度范围内都是线性的。所提出的方法的选择性通过使用不同的实验室制备的 SLD 与酸诱导或氧化诱导降解产物的混合物进行了测试，显示了 SLD 的特异性和可接受的回收率值。所提出的方法已成功应用于药物制剂中 SLD 的分析，没有添加剂的干扰。
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