A multi-metric evaluation of a sustainable capillary electrophoresis method for simultaneous therapeutic drug monitoring of Nilotinib and Ofloxacin in oncology clinics.

Cancer is the most threatening disease worldwide. Noticeably, most cancer patients are immune-compromised, so they are more susceptible to infections. The combination of the tyrosine kinase inhibitor nilotinib (NIL) with broad-spectrum antibiotics such as the fluoroquinolone ofloxacin (OFL) is clinically rationalized based on NIL's immunosuppressive effects and the need for infection prophylaxis in cancer patients. However, there is no published method for their in-vivo simultaneous determination in clinical biological specimens to support their pharmacokinetics and therapeutic monitoring. This study focuses on the development of a miniaturized capillary electrophoresis system-assisted with photodiode array detection (CE-PDA) for the simultaneous determination of NIL and OFL in clinical settings for analysis of plasma samples containing NIL and OFL. The conditions of electrophoretic separation of NIL, OFL, and sarafloxacin (SAR, as an internal standard), and the analytical procedures were successfully established. The electrophoretic separation of NIL, OFL, and SAR, as the internal standard, was achieved utilizing a fused silica capillary (58 cm length × 75 μm internal diameter) maintained at 25 °C using a background electrolyte solution composed of borate buffer (20 mM, pH 9.3) at a separation voltage of 30 kV. The linear range of the CE-PDA method in spiked rat plasma was determined to be 0.5-80 µg mL