Background The combination of daclatasvir (DCV) and sofosbuvir (SFV) is now widely used as an ideal treatment for hepatitis C virus (HCV) infection. For this purpose, simple, sensitive, rapid, and smart spectrophotometric methods were developed and validated for the determination of these drugs in their combined dosage form. Objective Development of smart, sensitive, low-cost spectrophotometric methods for the determination of DCV and SFV in their combined dosage form. Methods Ratio subtraction (RS), amplitude modulation (AM), and mean-centering spectrophotometric methods were established and validated for the estimation of SFV in the presence of DCV without previous separation, using a unified regression equation. Results A linearity range of 2.5–25.0 µg/mL was confirmed for the direct measurement of DCV at 316 nm (because there is no interference from SFV. Linearity was confirmed over a concentration range of 10.0–80.0 µg/mL for SFV. The current methods were established according to the ICH recommendations, and specificity was examined by testing synthetic mixtures of both drugs. They were tested on their tablet dosage form, and a good recovery was obtained. Conclusion The current methods proved to be simple, specific, and economical. A statistical study of the current ratio approaches and published methods showed there was no apparent statistical variation. Highlights Both antiviral agents can be quantified in the presence of each other by the current methods, which is a significant time- and cost-saving benefit of the developed methods. This benefit is even more important in the case of the combined dosage form (Darvoni® tablets) for the pharmaceutical market.

中文翻译：

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用于解决二元抗病毒混合物 Daclatasvir/Sofosbuvir 的部分重叠光谱的三种智能和原始分光光度数据处理比率技术：应用于组合剂型 Darvoni® 片剂

背景 daclatasvir (DCV) 和 sofosbuvir (SFV) 的组合现在被广泛用作丙型肝炎病毒 (HCV) 感染的理想治疗方法。为此，开发并验证了简单、灵敏、快速和智能的分光光度法，用于测定这些药物的组合剂型。目的 开发用于测定联合剂型中 DCV 和 SFV 的智能、灵敏、低成本的分光光度法。方法 使用统一的回归方程，建立并验证了比率减法 (RS)、幅度调制 (AM) 和均值中心分光光度计方法，用于在 DCV 存在且未预先分离的情况下估计 SFV。结果 线性范围为 2.5–25。