Utility of the food colorant erythrosine B as an effective green probe for quantitation of the anticancer sunitinib. Application to pharmaceutical formulations and human plasma.

Abstract

Sunitinib is a tyrosine kinase inhibitor used for the treatment of renal cell carcinoma and gastrointestinal stromal tumors. In this study, two spectroscopic methods, spectrofluorometric and spectrophotometric, were utilized to quantify sunitinib in different matrices. In method I, the native fluorescence of erythrosine B was quenched by forming ion-pair complex with increasing quantities of sunitinib. This approach was utilized for measuring sunitinib in its dosage forms and spiked plasma. After excitation at 528 nm, the quenching of fluorescence is linearly related to the concentration across the range of 0.05-0.5μg mL-1 at 550 nm in Britton-Robinson buffer (pH4.0), with a correlation value of 0.9999 and a high level of sensitivity with detection limit down to 10ng mL-1 . Method II relies on spectrophotometric measurements of the produced complex at 550 nm across a range of 0.5-10.0μg mL-1 , with good correlation value of 0.9999. This method has a detection limit down to 0.16 μg mL-1 . The proposed methodologies were validated according to International Conference on Harmonization (ICH) guidelines with satisfactory results. The stoichiometry of the reaction was determined through the application of Job's method, while the mechanism of quenching was investigated by employing the Stern-Volmer plot. The designated methods were used to estimate sunitinib in its capsules and in spiked human plasma. Additionally, the statistical analysis of the data revealed no substantial differences when compared to previous reported spectroscopic method. Green assessment tools provide further details about the eco-friendly nature of the methods.