Accurate, simple, and selective spectrophotometric and spectrodensitometric methods were developed and adopted to quantify velpatasvir (VPS) and sofosbuvir (SFV) concurrently in their pure forms and tablets. The spectrophotometric technique was based on the first derivative of ratio spectra (¹DD) technique and developed to determine VPS and SFV simultaneously in table formulation. However, the spectrodensitometric technique was based on thin-layer chromatography (TLC) and densitometry and developed to determine VPS and SFV simultaneously in tablet dosage form. Chromatographic separation was performed using chloroform:methanol 9.5:0.5 (%, v/v) as the mobile phase on glass-coated TLC plates. Detection was achieved using a 265-nm deuterium lamp in absorbance mode. Both analytical methods were validated according to the International Conference on Harmonization (ICH)-Q2B guidelines. The linearity in the range of concentration ranges of 1–50 μg/mL and 5–80 μg/mL were obtained for VPS and SFV, respectively, using ¹DD spectrometric method. However, the linearity in the range of 5–50 and 10–70 μg/band for VPS and SFV, respectively, were recorded using TLC–densitometric method. Accuracy was recorded ˃100% for VPS and SFV using both methods. This is the first TLC–densitometry method that can separate and quantify the studied mixture of the drugs. The proposed analytical methods were found to be accurate, precise, selective, robust and sensitive for simultaneous analysis of VPS and SFV in tablet dosage forms.

中文翻译：

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分光光度法和分光光度法定量一种新的抗病毒药物组合

开发了准确，简单，选择性的分光光度法和分光光度法，并同时定量了纯形式和片剂中的维帕他韦（VPS）和索非布韦（SFV）。分光光度法基于比率光谱的一阶导数（¹ DD）技术，并发展为在表配方中同时测定VPS和SFV。然而，分光光度法是基于薄层色谱（TLC）和光密度法，并发展为可同时测定片剂剂型中的VPS和SFV。色谱分离使用氯仿：甲醇9.5：0.5（％，v / v）作为玻璃涂层TLC板上的流动相。使用265 nm氘灯在吸收模式下进行检测。两种分析方法均根据国际协调会议（ICH）-Q2B指南进行了验证。对于VPS和SFV，分别在1–50μg/ mL和5–80μg/ mL的浓度范围内获得线性，其中使用¹DD光谱法。但是，使用TLC密度法记录的VPS和SFV的线性分别在5-50和10-70μg/ band范围内。使用这两种方法，VPS和SFV的准确度均记录为˃100％。这是第一种可以分离和定量研究药物混合物的TLC密度法。发现所提出的分析方法对于片剂剂型中的VPS和SFV的同时分析是准确，精确，选择性，鲁棒和灵敏的。