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高冲击幅度操纵(HIAM)技术用于提取两种固定剂量组合(FDC)基本光谱的能力——通过光谱对比角进行分光光度法纯度分析。

The power of High Impact Amplitude Manipulation (HIAM) technique for extracting the basic spectra of two Fixed-dose combinations (FDC) -Spectrophotometric purity analysis via spectral contrast angle.

作者信息

Saleh Sarah S, Lotfy Hayam M, Tiris Gizem, Erk Nevin, El-Naem Omnia A

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, October University for Modern Sciences and Arts (MSA), 11787 6th October, Egypt.

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, Cairo 11562, Egypt; Pharmaceutical Chemistry Department, Faculty of Pharmaceutical Science and Pharmaceutical Industries, Future University in Egypt, Cairo 11835, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2022 May 15;273:121036. doi: 10.1016/j.saa.2022.121036. Epub 2022 Feb 15.

DOI:10.1016/j.saa.2022.121036
PMID:35193003
Abstract

HIAM technique allows the extraction of the original constant signal of each single component out of interference signals of a mixture and further transformed into basic spectrum (D). It includes the methods: ratio subtraction coupled with unified constant subtraction (RS-UCS), constant center (CC) and constant extraction (CE). The technique was introduced for the analysis of two pharmaceutical formulations used to treat cardiovascular diseases. The formulations are binary combinations of Amlodipine (AML) with either Atorvastatin (ATR) or Candesartan (CND) which shows interefernce absorbance signals. The technique was valid over the linearity range of (5.0-35.0 µg/ml) for AML, ATR and CND with recovery percentage 100.40 ± 1.88 , 100.00 ± 0.86 and 99.83 ± 1.07, respectively . The extracted signals were tested for its purity by spectral contrast angle (cos θ) to illustrate the efficency of the HIAM technique where cos θ values ranges from (0.9902 to 0.9986). The presented technique was fully validated regarding ICH guidelines and were statistically compared using one-way ANOVA at 95% confidence.

摘要

HIAM技术能够从混合物的干扰信号中提取出每个单一成分的原始恒定信号,并进一步转化为基本光谱(D)。它包括以下方法:比率减法结合统一常数减法(RS-UCS)、恒定中心(CC)和恒定提取(CE)。该技术被引入用于分析两种用于治疗心血管疾病的药物制剂。这些制剂是氨氯地平(AML)与阿托伐他汀(ATR)或坎地沙坦(CND)的二元组合,它们显示出干扰吸收信号。该技术在AML、ATR和CND的线性范围(5.0 - 35.0 µg/ml)内有效,回收率分别为100.40 ± 1.88、100.00 ± 0.86和99.83 ± 1.07。通过光谱对比角(cos θ)对提取的信号进行纯度测试,以说明HIAM技术的效率,其中cos θ值范围为(0.9902至0.9986)。所提出的技术根据ICH指南进行了全面验证,并使用单向方差分析在95%置信度下进行了统计比较。

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