Mohamed Ekram H, Lotfy Hayam M, Hegazy Maha A, Mowaka Shereen
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, The British University in Egypt, El-Sherouk City, 11837, Egypt.
Pharmaceutical Chemistry Department, Faculty of Pharmaceutical Science & Pharmaceutical Industries, Future University, Cairo, 12311, Egypt.
Chem Cent J. 2017 May 25;11(1):43. doi: 10.1186/s13065-017-0270-8.
Analysis of complex mixture containing three or more components represented a challenge for analysts. New smart spectrophotometric methods have been recently evolved with no limitation. A study of different novel and smart spectrophotometric techniques for resolution of severely overlapping spectra were presented in this work utilizing isosbestic points present in different absorption spectra, normalized spectra as a divisor and dual wavelengths. A quaternary mixture of drotaverine (DRO), caffeine (CAF), paracetamol (PCT) and para-aminophenol (PAP) was taken as an example for application of the proposed techniques without any separation steps. The adopted techniques adopted of successive and progressive steps manipulating zero /or ratio /or derivative spectra. The proposed techniques includes eight novel and simple methods namely direct spectrophotometry after applying derivative transformation (DT) via multiplying by a decoding spectrum, spectrum subtraction (SS), advanced absorbance subtraction (AAS), advanced amplitude modulation (AAM), simultaneous derivative ratio (SDD), advanced ratio difference (ARD), induced ratio difference (IRD) and finally double divisor-ratio difference-dual wavelength (DD-RD-DW) methods.
The proposed methods were assessed by analyzing synthetic mixtures of the studied drugs. They were also successfully applied to commercial pharmaceutical formulations without interference from other dosage form additives. The methods were validated according to the ICH guidelines, accuracy, precision, repeatability, were found to be within the acceptable limits.
The proposed procedures are accurate, simple and reproducible and yet economic. They are also sensitive and selective and could be used for routine analysis of complex most of the binary, ternary and quaternary mixtures and even more complex mixtures.
对含有三种或更多成分的复杂混合物进行分析,对分析人员来说是一项挑战。最近已开发出无限制的新型智能分光光度法。本研究利用不同吸收光谱中存在的等吸收点、归一化光谱作为除数和双波长,介绍了用于解析严重重叠光谱的不同新型智能分光光度技术。以屈他维林(DRO)、咖啡因(CAF)、对乙酰氨基酚(PCT)和对氨基苯酚(PAP)的四元混合物为例,在不进行任何分离步骤的情况下应用所提出的技术。所采用的技术采用连续和渐进的步骤来处理零/或比率/或导数光谱。所提出的技术包括八种新颖且简单的方法,即通过乘以解码光谱应用导数变换(DT)后的直接分光光度法、光谱减法(SS)、高级吸光度减法(AAS)、高级幅度调制(AAM)、同时导数比率(SDD)、高级比率差(ARD)、诱导比率差(IRD),最后是双除数 - 比率差 - 双波长(DD - RD - DW)方法。
通过分析所研究药物的合成混合物对所提出的方法进行了评估。它们还成功应用于市售药物制剂,不受其他剂型添加剂的干扰。根据国际人用药品注册技术协调会(ICH)指南对方法进行了验证,准确度、精密度、重复性均在可接受范围内。
所提出的方法准确、简单、可重复且经济。它们还具有灵敏性和选择性,可用于大多数二元、三元和四元复杂混合物甚至更复杂混合物的常规分析。