Analytical and Food Chemistry Department, Faculty of Pharmacy, Aleppo University, Aleppo, Syria.
Analytical and Food Chemistry Department, Faculty of Pharmacy, Aleppo University, Aleppo, Syria.
Spectrochim Acta A Mol Biomol Spectrosc. 2019 Aug 5;219:186-194. doi: 10.1016/j.saa.2019.04.036. Epub 2019 Apr 19.
Comparative study of the spectrophotometric strategies utilizing the isoabsorptive point present in overlapped absorption spectra of ciprofloxacin and fluocinolone acetonide in their recently delivered co-formulation, was presented. Four spectrophotometric approaches were developed, dependent on the determination of the leveling effect of isoabsorptive point in their zero order absorption spectra or its manipulated form ratio spectra as it retains an isosbestic point. The proposed strategy was based on determination of the total concentrations of the proposed drugs at iso-point, either via zero order or ratio spectra, while one of the recommended methods determined the concentration of the major component, so the concentration of the minor component was obtained by differentiation. The first, second and third methods are utilizing isoabsorptive point at zero order absorption spectrum to quantify total concentration of the cited component, while the major component could be selectively determined using either absorbance at its maxima (IsoP-D), or area under the peak method (IsoP-AUC), or first derivative technique (IsoP-D). The fourth method is ratio manipulated isoabsorptive point in ratio spectrum, namely the amplitude modulation method (AM), using an unified regression equation for the total and major component concentrations, separately. The four methods were applied practically for the analysis of the binary mixtures of ciprofloxacin hydrochloride (CIP) and fluocinolone acetonide (FLU) in a recently otic solution form in challengeable ratio12:1respectively, without the need of any previous stages such as separation, dilution or standard addition. The methods were successfully validated as per ICH guidelines. The outcomes data gained from those submitted techniques were statistically assimilated with official ones. However, no radical differences were noticed.
本文提出了一种比较研究，即在最近推出的共配方中，利用环丙沙星和氟轻松丙酮重叠吸收光谱中的等吸收点，对分光光度策略进行了研究。建立了四种分光光度法，取决于在其零阶吸收光谱或其操纵的比光谱中确定等吸收点的平抑效应，因为它保留了等色点。该方法基于在等点处测定所提议药物的总浓度，无论是通过零阶还是比光谱，而推荐的方法之一测定主要成分的浓度，因此可以通过微分获得次要成分的浓度。第一、第二和第三种方法利用零阶吸收光谱中的等吸收点来定量测定所引用成分的总浓度，而主要成分可以通过其最大值处的吸光度（IsoP-D）、峰下面积法（IsoP-AUC）或一阶导数技术（IsoP-D）进行选择性测定。第四种方法是在比光谱中操纵比等吸收点，即幅度调制法（AM），分别使用统一的回归方程来计算总浓度和主要成分浓度。这四种方法实际应用于分析最近耳用溶液形式的盐酸环丙沙星（CIP）和氟轻松丙酮（FLU）的二元混合物，在挑战性的 12:1 比例下，无需任何分离、稀释或标准添加等预处理步骤。该方法根据 ICH 指南进行了成功验证。从这些提交的技术中获得的数据结果与官方数据进行了统计融合。然而，没有发现明显的差异。
