Lotfy Hayam M, Saleh Sarah S, Hassan Nagiba Y, Salem Hesham
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr-El Aini Street, 11562 Cairo, Egypt.
Analytical Chemistry Department, Faculty of Pharmacy, October University for Modern Sciences and Arts (MSA), 11787 6[th] October City, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2015 Feb 5;136 Pt C:1786-96. doi: 10.1016/j.saa.2014.10.084. Epub 2014 Oct 31.
This work presents the application of different spectrophotometric techniques based on two wavelengths for the determination of severely overlapped spectral components in a binary mixture without prior separation. Four novel spectrophotometric methods were developed namely: induced dual wavelength method (IDW), dual wavelength resolution technique (DWRT), advanced amplitude modulation method (AAM) and induced amplitude modulation method (IAM). The results of the novel methods were compared to that of three well-established methods which were: dual wavelength method (DW), Vierordt's method (VD) and bivariate method (BV). The developed methods were applied for the analysis of the binary mixture of hydrocortisone acetate (HCA) and fusidic acid (FSA) formulated as topical cream accompanied by the determination of methyl paraben and propyl paraben present as preservatives. The specificity of the novel methods was investigated by analyzing laboratory prepared mixtures and the combined dosage form. The methods were validated as per ICH guidelines where accuracy, repeatability, inter-day precision and robustness were found to be within the acceptable limits. The results obtained from the proposed methods were statistically compared with official ones where no significant difference was observed. No difference was observed between the obtained results when compared to the reported HPLC method, which proved that the developed methods could be alternative to HPLC techniques in quality control laboratories.
本研究介绍了基于两个波长的不同分光光度技术在无需预先分离的情况下测定二元混合物中严重重叠光谱成分的应用。开发了四种新型分光光度法，即：诱导双波长法（IDW）、双波长分辨率技术（DWRT）、先进调幅法（AAM）和诱导调幅法（IAM）。将这些新方法的结果与三种成熟方法的结果进行了比较，这三种方法分别是：双波长法（DW）、菲尔奥德特法（VD）和双变量法（BV）。所开发的方法应用于醋酸氢化可的松（HCA）和夫西地酸（FSA）二元混合物的分析，该混合物制成了外用乳膏，并同时测定了作为防腐剂的对羟基苯甲酸甲酯和对羟基苯甲酸丙酯。通过分析实验室制备的混合物和复方剂型研究了新方法的特异性。按照ICH指南对这些方法进行了验证，发现准确度、重复性、日间精密度和稳健性均在可接受范围内。将所提出方法得到的结果与官方方法进行了统计学比较，未观察到显著差异。与报道的HPLC方法相比，所得结果之间没有差异，这证明所开发的方法可在质量控制实验室中替代HPLC技术。
