Development and validation of a new bioanalytical method for quantification of CDK4/6 inhibitor in Spiked Human Plasma by HPLC-UV

Abstract A sensitive and accurate high performance liquid chromatography method utilizing ultraviolet/visible light detection (HPLC-UV) for the quantification of Ribociclib in Spiked Human Plasma by HPLC-UV was developed validated. (RCB) internal standard (IS), Trifluridine, were first extracted from plasma samples a simple Protein Precipitation extraction using Acetonitrile. concentration RCB then analyzed applying reversed phase Orochem orosil C18 (4.6 mm × 250 mm, 5 μ) elution with isocratic mobile consisting 10 mM phosphate buffer – Acetonitrile (60:40, v/v) adjusted to pH 3.0 at flow rate 1.0 ml/min. Detection IS subsequently done wavelength 260 nm. The limit ng/ml. calibration curve linear (R2>0.998) over range 10-1000 For human plasma, accuracy precision within ±15% ≤15%, respectively, all concentrations, except lower quantification, where they ≤20%.