Development and validation of RP-HPLC method for simultaneous quantification of the anticancer agents, nilotinib and sorafenib: Application in In-vitro analysis

In this research, a reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of two tyrosine kinase inhibitors, nilotinib and sorafenib. Separation was performed on an Agilent C۱۸ column (۴.۶×۲۵۰ mm, ۵µm) with mobile phase composition of potassium dihydrogen phosphate buffer (۲۵ mM, pH ۴.۲) and acetonitrile (۳۵:۶۵ v/v) at ۱.۲ mL/min with UV detection at ۲۶۵ nm. Specificity, linearity, precision, accuracy, and robustness of the proposed method were all assessed. Nilotinib and sorafenib had estimated retention times of ۵.۱ and ۵.۹ minutes, respectively. Linear concentration ranges for nilotinib and sorafenib, were determined as ۰.۰۵-۱ µg/mL and ۱۰-۴۵ µg/mL with comparable coefficient correlations (۰.۹۹۹). For nilotinib and sorafenib, the limits of detection (LOD) were determined as ۰.۰۳۰ and ۰.۰۲۰ µg/mL, while the limits of quantification (LOQ) were ۰.۱۰۱ and ۰.۰۶۹ µg/mL respectively.

Keywords:

HPLC , Nilotinib , sorafenib , Determination , tyrosine kinase inhibitor