Abstract
Epirubicin, olaparib and ribociclib are three important anti-cancer agents representing distinct classes: an anthracycline (epirubicin), a PARP inhibitor (olaparib) and a CDK4/6 inhibitor (ribociclib). Analytical quantification of these drugs in biological fluids or in dosage forms often uses high-performance or ultra-performance liquid chromatography (HPLC or RP-HPLC), often coupled with ultraviolet (UV) or photo-diode-array detection (PDA), occasionally with mass spectrometric detection (MS). Within this paper, a rapid HPLC method with PDA detection for simultaneous quantitation of these analytes in pharmaceutical dosage forms is presented. The separation was carried out on a Vanquish Core (Thermo Scientific, USA) liquid chromatograph coupled with a PDA detector. Solid Phase Extraction (SPE) using Oasis PRiME HLB® cartridges was employed as sample preparation procedure. Chromatography was performed by using an unconventional porous graphitic carbon column (HypercarbTM); a gradient elution was carried out using a mixture of acetonitrile/tetrahydrofuran. The flow rate of the mobile phase and the injected volume were 1mL/min and 20μL, respectively. The column compartment temperature was set to 60°C. Each chromatographic peak was integrated at its maximum absorption wavelength. Quantification was performed with external standard method. All validation data were assessed according to European Medicines Agency (EMA) Guidelines, regarding stability, limit of detection/quantitation, precision, accuracy and linearity. The presented method was applied in pharmaceutical dosage forms analysis.