Lotfy Hayam Mahmoud, Salem Hesham, Abdelkawy Mohammad, Samir Ahmed
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562 Cairo, Egypt.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Deraya University, Minia, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2015 Apr 5;140:294-304. doi: 10.1016/j.saa.2014.12.059. Epub 2015 Jan 9.
Five spectrophotometric methods were successfully developed and validated for the determination of betamethasone valerate and fusidic acid in their binary mixture. Those methods are isoabsorptive point method combined with the first derivative (ISO Point--D1) and the recently developed and well established methods namely ratio difference (RD) and constant center coupled with spectrum subtraction (CC) methods, in addition to derivative ratio (1DD) and mean centering of ratio spectra (MCR). New enrichment technique called spectrum addition technique was used instead of traditional spiking technique. The proposed spectrophotometric procedures do not require any separation steps. Accuracy, precision and linearity ranges of the proposed methods were determined and the specificity was assessed by analyzing synthetic mixtures of both drugs. They were applied to their pharmaceutical formulation and the results obtained were statistically compared to that of official methods. The statistical comparison showed that there is no significant difference between the proposed methods and the official ones regarding both accuracy and precision.
成功开发并验证了五种分光光度法，用于测定戊酸倍他米松和夫西地酸二元混合物中的含量。这些方法包括等吸收点法结合一阶导数（ISO点-D1）以及最近开发并成熟的方法，即比率差值（RD）和恒定中心结合光谱减法（CC）方法，此外还有导数比率（1DD）和比率光谱的平均中心化（MCR）。使用了一种称为光谱添加技术的新富集技术，而不是传统的加样技术。所提出的分光光度法无需任何分离步骤。测定了所提出方法的准确度、精密度和线性范围，并通过分析两种药物的合成混合物评估了特异性。将它们应用于其药物制剂，并将所得结果与官方方法的结果进行统计学比较。统计比较表明，所提出的方法与官方方法在准确度和精密度方面均无显著差异。
