Development and validation of an LC–MS/MS method for the quantification of Lurasidone in rabbit plasma

Abstract

Liquid chromatographic mass spectrometry was used to develop the current bioanalytical method, which was newly established to determine the quantity of Lurasidone in plasma estimation of rabbits. Methods: Chromatographic separation was carried out on an Atlantis HILIC Silica C18 column (150 × 4.6 mm, 5 μm, Waters, USA), analytical column with a mobile phase consisting of acetonitrile: 0.1% formic acid, 90:10 ratio. The production mass value of Lurasidone was found m/z + 493.25 (parent) →266.3 (product) and m/z + 326.6 (parent)→245.31 (product) for clozapine. Results: Extraction of the drug from the spiked plasma was accomplished using the liquid-liquid extraction technique. As evidenced by extraction recovery (98.86%) (Interference = 0), matrix and analyte selectivity were high. A linear calibration curve was seen from 0.5 to 5000 ng/ml, and all kinds of stability study results (99.87%) were good. Accuracy ranged from 96.21 to 98.42%, with precision < 2% at all quality control levels. In pharmacokinetic analysis, Lurasidone has an AUC0−t of 122 ± 7.52 h.ng/ml. The half-life of elimination (t1/2) is 7.46 ± 1.66 h. Conclusion: The method, considered a novel and validated bioanalytical approach based on experimental findings, was utilized for pharmacokinetic studies of commercial formulations using rabbit plasma samples.