Hassan Said A, Elzanfaly Eman S, Salem Maissa Y, El-Zeany Badr A
Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562 Cairo, Egypt.
Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562 Cairo, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2016 Jan 15;153:132-42. doi: 10.1016/j.saa.2015.07.109. Epub 2015 Aug 10.
A novel spectrophotometric method was developed for determination of ternary mixtures without previous separation, showing significant advantages over conventional methods. The new method is based on mean centering of double divisor ratio spectra. The mathematical explanation of the procedure is illustrated. The method was evaluated by determination of model ternary mixture and by the determination of Amlodipine (AML), Aliskiren (ALI) and Hydrochlorothiazide (HCT) in laboratory prepared mixtures and in a commercial pharmaceutical preparation. For proper presentation of the advantages and applicability of the new method, a comparative study was established between the new mean centering of double divisor ratio spectra (MCDD) and two similar methods used for analysis of ternary mixtures, namely mean centering (MC) and double divisor of ratio spectra-derivative spectrophotometry (DDRS-DS). The method was also compared with a reported one for analysis of the pharmaceutical preparation. The method was validated according to the ICH guidelines and accuracy, precision, repeatability and robustness were found to be within the acceptable limits.
开发了一种无需预先分离即可测定三元混合物的新型分光光度法,与传统方法相比具有显著优势。该新方法基于双除数比光谱的均值中心化。阐述了该方法的数学原理。通过测定模型三元混合物以及实验室制备混合物和市售药物制剂中的氨氯地平(AML)、阿利吉仑(ALI)和氢氯噻嗪(HCT)对该方法进行了评估。为了恰当展示新方法的优势和适用性,在新的双除数比光谱均值中心化(MCDD)与用于分析三元混合物的两种类似方法(即均值中心化(MC)和比光谱双除数导数分光光度法(DDRS-DS))之间进行了对比研究。该方法还与一种已报道的用于分析药物制剂的方法进行了比较。根据国际人用药品注册技术协调会(ICH)指南对该方法进行了验证,发现准确度、精密度、重复性和稳健性均在可接受范围内。