Youssef Rasha M, El-Nahass Sara A, Soliman Sobhi A, Younis Sameh E
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, Alexandria, Egypt.
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Pharos University in Alexandria, Alexandria, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2021 Jul 15;256:119748. doi: 10.1016/j.saa.2021.119748. Epub 2021 Mar 26.
A hybrid Spectrofluorimetric method was developed for the simultaneous determination of binary mixtures, without prior separation steps. It coupled synchronous spectrofluorimetry with derivative ratio mathematical treatment. The method was applied successfully to quantify a new model binary mixture consisting of Valsartan (VAL) and Sacubitril (SAC). This mixture was recently approved by FDA as LCZ696. It added a great value in reducing morbidity and mortality in resistant heart failure (HF) patients. First derivative ratio synchronous fluorescence was measured at 258-295 (peak-to-peak) and 204 nm for VAL and SAC, respectively. ICH guidelines were fulfilled for the method validation. VAL and SAC showed linear responses in the range of 60-200 and 20-200 ng mL, respectively. The proposed method was compared, in details, with the reported ones. Its high accuracy, selectivity, simplicity and affordable cost recommend method application in large-scale routine analysis of LCZ696 tablets. Moreover, reliable application of this new integrated spectrofluorimetric method suggests expansion of its application for various therapeutic combinations and different matrices.
开发了一种无需预先分离步骤即可同时测定二元混合物的混合荧光分光光度法。它将同步荧光分光光度法与导数比数学处理相结合。该方法成功应用于定量由缬沙坦（VAL）和沙库巴曲（SAC）组成的新型二元混合物模型。该混合物最近被美国食品药品监督管理局批准为LCZ696。它在降低难治性心力衰竭（HF）患者的发病率和死亡率方面具有重要价值。分别在258 - 295（峰峰值）和204 nm处测量VAL和SAC的一阶导数比同步荧光。该方法验证符合国际人用药品注册技术协调会指南。VAL和SAC分别在60 - 200和20 - 200 ng/mL范围内呈现线性响应。将该方法与已报道的方法进行了详细比较。其高准确度、选择性、简便性和低成本推荐该方法应用于LCZ696片剂的大规模常规分析。此外，这种新型综合荧光分光光度法的可靠应用表明其应用可扩展到各种治疗组合和不同基质。
