A fast, low-cost, sensitive, and selective spectrofluorimetric method for the determination of ledipasvir was developed and validated. The method is based on an enhancement in the native fluorescence intensity of ledipasvir by 500% of its original value by the formation of hydrogen bonds between the cited drug and Tween-20 in the micellar system (pH = 5.0). All fluorescence measurements were carried out at 425 nm and 340 nm for emission and excitation wavelengths, respectively. A linear relationship between the concentration of ledipasvir and the observed fluorescence intensity was achieved in the range of 0.1-2.0 μg ml-1 with 0.028, 0.084 μg ml-1 , for detection and quantitation limits, respectively. The acquired selectivity and sensitivity using the proposed method facilitate the analysis of ledipasvir in spiked human plasma with sufficient percentage recovery (95.36-99.30%). The proposed method was developed and validated according to International Council for Harmonisation (ICH) guidelines. Moreover, the cited drug was successfully determined in its pharmaceutical dosage form using the proposed method. In addition, the validity of the proposed results was statistically confirmed using Student's t-test, variance ratio F-test, and interval hypothesis test.

中文翻译：

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基于胶束的荧光分光光度法在存在索非布韦的情况下选择性测定ledipasvir：应用于剂型和人血浆。

建立并验证了一种快速，低成本，灵敏且选择性的荧光分光光度法测定来昔帕韦的方法。该方法的基础是通过在胶束系统中（pH = 5.0）在所引用药物和Tween-20之间形成氢键，来使莱迪帕韦的天然荧光强度提高其原始值的500％。所有荧光测量分别针对发射和激发波长在425 nm和340 nm进行。在检测和定量限分别为0.1-2.0μgml-1和0.028、0.084μgml-1的范围内，实现了ledipasvir浓度与观察到的荧光强度之间的线性关系。使用所提出的方法获得的选择性和灵敏度有助于在加标的人血浆中分析ledipasvir，并具有足够的回收率（95.36-99.30％）。所提出的方法是根据国际协调理事会（ICH）指南开发和验证的。而且，使用所提出的方法成功地以其药物剂型确定了所引用的药物。此外，使用学生t检验，方差比F检验和区间假设检验在统计学上证实了所提出结果的有效性。