Abstract Two simple and rapid analytical assay methods were developed and validated utilizing spectroscopic techniques for sensitive and selective estimation of daclatasvir dihydrochloride in pharmaceutical preparations based on anion pair complex formation with eosin Y. The maximum absorbance of the formed complex was achieved at 545 nm in 0.1 M acetate buffer at pH 3.2 and Beer's law for absorbance against daclatasvir dihydrochloride concentration obeyed in the range of 1.0–10.0 μg mL−1 for the spectrophotometric method (method I). The technicality of spectrofluorimetric method (method II) based on measuring the quenching effect of daclatasvir dihydrochloride on the native fluorescence intensity of eosin Y at the same pH and the measurements were accomplished at 543 nm after excitation at 301 nm. The rectilinear calibration graph between daclatasvir dihydrochloride concentration and the fluorescence quenching values (ΔFI) was achieved over the range of 0.1–2.0 μg mL−1. The formation constant for the binary complex was 4.4 × 104 and Gibb's free energy change was −2.7 × 104 J mol−1. Both methods were validated in agreement with ICH guidelines and a successfully applied for the analysis dosage forms with good % recovery. A suggestion for the reaction pathway was supposed.

中文翻译：

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用于分析 HCV 抗病毒药物达卡他韦二盐酸盐的呫吨光谱探针，通过可行的络合反应

摘要 基于与伊红 Y 形成阴离子对复合物，利用光谱技术开发和验证了两种简单快速的分析测定方法，用于灵敏和选择性地评估药物制剂中的达卡他韦二盐酸盐。形成的复合物的最大吸光度在 545 nm 处达到 0.1对于分光光度法（方法 I），pH 3.2 的 M 醋酸盐缓冲液和针对 daclatasvir 二盐酸盐浓度的吸光度遵循 Beer 定律在 1.0–10.0 μg mL-1 范围内。分光荧光法（方法II）的技术性基于测量daclatasvir dihydrochloride 在相同pH 下对曙红Y 的天然荧光强度的猝灭效应，并在301 nm 激发后在543 nm 处完成测量。达卡他韦二盐酸盐浓度与荧光猝灭值 (ΔFI) 之间的直线校准图在 0.1–2.0 μg mL-1 范围内实现。二元配合物的形成常数为 4.4 × 104，吉布氏自由能变化为 -2.7 × 104 J mol-1。两种方法均经验证符合 ICH 指南，并成功应用于具有良好回收率的分析剂型。提出了对反应途径的建议。两种方法均经验证符合 ICH 指南，并成功应用于具有良好回收率的分析剂型。提出了对反应途径的建议。两种方法均经验证符合 ICH 指南，并成功应用于具有良好回收率的分析剂型。提出了对反应途径的建议。