数据的智能光谱处理，用于估算常用的非处方（OTC）复方药物；盐酸伪麻黄碱和布洛芬。
Smart Spectral Processing of Data for the estimation of Commonly Used Over-the-counter (OTC) Co-formulated drug; Pseudoephedrine hydrochloride and Ibuprofen.
机构信息
Pharmaceutical Chemistry Department, Faculty of Pharmaceutical Sciences and Pharmaceutical Industries, Future University in Egypt, Cairo, Egypt; Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
Pharmaceutical Chemistry Department, Faculty of Pharmaceutical Sciences and Pharmaceutical Industries, Future University in Egypt, Cairo, Egypt.
出版信息
Spectrochim Acta A Mol Biomol Spectrosc. 2019 Dec 5;223:117322. doi: 10.1016/j.saa.2019.117322. Epub 2019 Jun 27.
Oral pharmaceutical preparation containing pseudoephedrine hydrochloride (PSE) and ibuprofen (IBU) is widely prescribed as over- the- counter (OTC) for treatment of common cold-sinus. Development of four precise and accurate spectrophotometric methods are established for the concurrent determination of (PSE) and (IBU)in this preparation exploiting zero and/or ratio spectra. Method I is a dual wavelength method (DW). method II is a ratio difference method (RD), method III is a constant multiplication coupled with spectrum subtraction method (CM-SS) and method IV is a constant center coupled with spectrum subtraction method (CC-SS). While, absorbance correction method (AC) is successfully established for the determination of (IBU) only exploiting zero order absorption spectra. The calibration curves are linear over the concentration range of 100.0-900.0 μg/mL for (PSE) and 200.0-1000.0 μg/mL for (IBU). No separation steps are required for the spectrophotometric procedures which augments their simplicity. Analyzing synthetic mixtures of the cited drugs evaluated the specificity of the applied methods. Validation of the analysis results have been statistically performed confirming the accuracy and reproducibility of the proposed method through recovery studies which were carried out by following ICH guidelines. Thus, the developed methods can be successfully applied routinely in quality control laboratory.
含有盐酸伪麻黄碱（PSE）和布洛芬（IBU）的口服药物制剂被广泛开为非处方药（OTC），用于治疗普通感冒和鼻窦炎。本研究建立了四种精确、准确的分光光度法，利用零和/或比值光谱同时测定该制剂中的（PSE）和（IBU）。方法 I 是双波长法（DW）。方法 II 是比值差法（RD），方法 III 是常数乘法与光谱减法法（CM-SS），方法 IV 是常数中心与光谱减法法（CC-SS）。而，仅利用零阶吸收光谱成功建立了吸收校正法（AC），用于测定（IBU）。（PSE）的校准曲线在 100.0-900.0μg/mL 的浓度范围内呈线性，（IBU）的校准曲线在 200.0-1000.0μg/mL 的浓度范围内呈线性。分光光度法不需要分离步骤，增加了其简单性。分析合成的混合药物评估了所应用方法的特异性。通过遵循 ICH 指南进行回收研究，对分析结果的验证进行了统计学处理，通过回收研究证实了所提出方法的准确性和重现性。因此，所开发的方法可以成功地常规应用于质量控制实验室。
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