Abdelazim Ahmed H, Shahin Mohammed, Abu-Khadra Ahmed S
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Damanhour University, Beheira, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2021 May 5;252:119540. doi: 10.1016/j.saa.2021.119540. Epub 2021 Feb 3.
Four chemometric assisted spectrophotometric models were developed for the quantitative analysis of velpatasvir and sofosbuvir, in their newly FDA approved pharmaceutical dosage form. Due to the existed overlap of the scanned absorption spectra between velpatasvir and sofosbuvir, this resulted in degree of difficulty of the possibility of the conventional spectrophotometric methods to quantify and analyze the cited drugs simultaneously. Classical least squares, principal component regression, partial least squares and genetic algorithm partial least squares were designed and compared for the quantitative analysis of velpatasvir and sofosbuvir in their binary mixture. Experimental design for different concentrations of the studied drugs was done based on the spectral sensitivity of velpatasvir and sofosbuvir and the confirmed ratio of the two drugs in the commercial pharmaceutical dosage form. Optimization of the described models was adopted with the aid of five-levels, two factors experimental design. Successfully quantitative assay of the drugs in Epclusa® tablets was done by the proposed models. Statistically comparative analysis for the obtained models results with another published capillary electrophoresis quantitative analytical method was performed. It is noteworthy mentioning that there was no significant difference between the proposed models and the published method with respect to the accepted statistical parameters.
开发了四种化学计量学辅助分光光度法模型，用于定量分析新获得美国食品药品监督管理局（FDA）批准的药物剂型中的维帕他韦和索磷布韦。由于维帕他韦和索磷布韦扫描吸收光谱存在重叠，这导致传统分光光度法难以同时对上述药物进行定量分析。设计并比较了经典最小二乘法、主成分回归法、偏最小二乘法和遗传算法偏最小二乘法，用于二元混合物中维帕他韦和索磷布韦的定量分析。根据维帕他韦和索磷布韦的光谱灵敏度以及市售药物剂型中两种药物的确定比例，对不同浓度的研究药物进行实验设计。借助五级二因素实验设计对所述模型进行优化。所提出的模型成功地对Epclusa®片剂中的药物进行了定量测定。对获得的模型结果与另一种已发表的毛细管电泳定量分析方法进行了统计学比较分析。值得一提的是，在所接受的统计参数方面，所提出的模型与已发表的方法之间没有显著差异。
