Micelle sensitized synchronous spectrofluorimetric approaches for the simultaneous determination of simeprevir and ledipasvir: Application to pharmaceutical formulations and human plasma

Simeprevir (SMV) is commonly co-administered with ledipasvir (LDS) and sofosbuvir (SOF) as an effective combination regimen for treatment naive hepatitis C virus infected patients. In the present study, two spectrofluorimetric approaches were combined together for the development of highly sensitive, rapid, simple and accurate method for simultaneous quantification of SMV and LDS. The native fluorescence intensity values of SMV and LDS were enhanced by the addition of Tween-80 micellar system, while second derivative of the synchronous fluorescence intensity of the drugs at Δλ = 120 nm enabled the determination of both drug concomitantly. Different experimental parameters affecting the synchronous fluorescence of the cited drugs were carefully evaluated for their optimization. The peak amplitudes of the second derivative synchronous fluorimetry were measured at 429 nm for SMV and at 417 nm for LDS. The fluorescence-concentration plots were rectilinear over the range of 60–1500 and 36–540 ng mL−1 with lower detection limits of 9.0 and 6.0 ng mL−1 and quantification limits of 27.0 and 17.0 ng mL−1 for SMV and LDS respectively. The method was successfully applied for the determination of both drugs in their pure forms as well as their pharmaceutical products and human plasma without any significant interference. Statistical comparison with the reported method revealed excellent accuracy and precision of the proposed method. © 2020