Bioanalytical Method Development and Validation of Selinexor in Rat Plasma by Liquid Chromatography-Tandem Mass Spectrometry

A simple, rapid, precise, sensitive, and reproducible reverse-phase high-performance liquid chromatography (RPHPLC) LCMS/MS method has been developed for the bioanalytical Selinexor with D6-Selinexor as Internal Standard in pharmaceutical dosage form. Chromatographic separation of was achieved on Waters Alliance-e2695, by using X-Bridge phenyl, 150x4.6mm, 3.5μm column, mobile phase containing 0.1% Formic acid & Acetonitrile ratio 80:20% v/v. The flow rate 1.0 ml/min; detection carried out absorption at 225nm a photodiode array detector ambient temperature. validated to fulfill International Conference Harmonization (ICH) requirements this validation included specificity, selectivity, matrix effect, linearity, limit (LOD), quantification (LOQ), precision, accuracy. proposed Bio-analytical according USFDA guidelines. This found be very economical, suitable, accurate, stable pharmacokinetic analysis study its stability. calibration curve linear over concentration range from 0 40 ng/ml, lower 12.5 ng/ml. accuracy precision were within acceptable ±20% quantitation ±15% other concentrations. unstable room temperature it showed more than 25% loss after 24 h. While, is refrigerator 40C auto-sampler, freeze/thaw cycles, 30 days storage freezer 35 ± 20C. All results confirmed that suitable intended use routine quality control an assay drugs.