Saleh Sarah S, Lotfy Hayam M, Hassan Nagiba Y, Salem Hesham
Analytical Chemistry Department, Faculty of Pharmacy, October University for Modern Sciences and Arts (MSA), 11787 6th October City, Egypt.
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr-El Aini Street, 11562 Cairo, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2014 Nov 11;132:239-48. doi: 10.1016/j.saa.2014.05.004. Epub 2014 May 13.
This work represents a comparative study of a novel progressive spectrophotometric resolution technique namely, amplitude center method (ACM), versus the well-established successive spectrophotometric resolution techniques namely; successive derivative subtraction (SDS); successive derivative of ratio spectra (SDR) and mean centering of ratio spectra (MCR). All the proposed spectrophotometric techniques consist of several consecutive steps utilizing ratio and/or derivative spectra. The novel amplitude center method (ACM) can be used for the determination of ternary mixtures using single divisor where the concentrations of the components are determined through progressive manipulation performed on the same ratio spectrum. Those methods were applied for the analysis of the ternary mixture of chloramphenicol (CHL), dexamethasone sodium phosphate (DXM) and tetryzoline hydrochloride (TZH) in eye drops in the presence of benzalkonium chloride as a preservative. The proposed methods were checked using laboratory-prepared mixtures and were successfully applied for the analysis of pharmaceutical formulation containing the cited drugs. The proposed methods were validated according to the ICH guidelines. A comparative study was conducted between those methods regarding simplicity, limitation and sensitivity. The obtained results were statistically compared with those obtained from the official BP methods, showing no significant difference with respect to accuracy and precision.
本研究对一种新型的渐进式分光光度法分辨率技术即振幅中心法（ACM），与成熟的连续分光光度法分辨率技术即连续导数减法（SDS）、比率光谱的连续导数（SDR）和比率光谱的均值中心化（MCR）进行了比较。所有提出的分光光度技术都由利用比率和/或导数光谱的几个连续步骤组成。新型的振幅中心法（ACM）可用于使用单一除数测定三元混合物，其中各组分的浓度通过对同一比率光谱进行渐进操作来确定。这些方法被应用于在有苯扎氯铵作为防腐剂的情况下，分析滴眼液中氯霉素（CHL）、地塞米松磷酸钠（DXM）和盐酸四氢唑啉（TZH）的三元混合物。所提出的方法通过实验室制备的混合物进行检验，并成功应用于含有所述药物的药物制剂分析。所提出的方法根据国际人用药品注册技术协调会（ICH）指南进行了验证。对这些方法在简便性、局限性和灵敏度方面进行了比较研究。将所得结果与从英国药典（BP）官方方法获得的结果进行了统计学比较，结果表明在准确性和精密度方面没有显著差异。
