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NEW APPROACH IN DETERMINING IBRUTINIB IN HUMAN PLASMA BY HPLC-DAD AND APPLICATION OF THE METHOD IN A PRELIMINARY PHARMACOKINETIC STUDY

DANIELA MARIA CROITORU ¹, COSTEL-VALENTIN MANDA ^1*, MIHAIL-VIRGIL BOLDEANU ², IONELA ROTARU ², SIMONA-DANIELA NEAMȚU ¹, JOHNY NEAMȚU ¹, OCTAVIAN CROITORU ¹

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A simple, sensitive and specific liquid chromatographic method is developed and validated for qualitative and quantitative analysis of ibrutinib in human plasma. Liquid-liquid extraction with ethyl acetate is used for sample preparation within this method. Reverse phase high performance liquid chromatography with diode array detection (RP-HPLC-DAD) analysis is performed which employs a C18 Hypersil GOLD column with a mobile phase acetonitrile: methanol: buffer solution pH 4.7 sodium acetate 10 mM and acetic acid 10 mM, 40:20:40 (v/v/v) with isocratic elution at a flow rate of 1 mL/min. Regarding sample preparation procedure, protein precipitation was investigated and different extraction solvents or extraction conditions were optimized. Selectivity and sensibility were also improved in order to accurately determine low concentrations of ibrutinib by correct selection of both mobile phase and detection wavelength used for quantitation.