Stability Indicating LC–ESI-MS/MS Method Development and Validation for the Quantitation of Lurbinectedin in Biological Matrices.

Abstract

The anticancer drug lurbinectedin was measured in plasma samples using a newly designed and validated LC-ESI-MS/MS method. The drug’s examination was conducted using ledipasvir as the internal standard. Following the liquid liquid extraction of 200 μL of plasma, the samples were separated using a ZorbaxSB (25 0mm x4.6 mm, 5 µm)C18 column. The mobile phase comprised of 0.1 %V/V formic acid and acetonitrile in the fraction of 10:90, and an infusion flow rate was 0.80mL/min. The analytes were eluted in 3.5 minutes total. Using a concentration range of 1.50 to 5000ng/mL of lurbinectedin and a correlation coefficient value of 0.9994, the method was validated in compliance with FDA standard standards. Assay accuracy ranged from 95.31% to 104.06% of the nominal values, and both intra- and inter-day precision results were within 4.32%. For the analyte at the LQC level, the matrix factor varies from 94.25% to 104.85% with a %CV of 4.61, whereas at the HQC level, it ranges from 94.62% to 103.88% with a %CV of 4.02. The results of the stability tests show that the approach is quite stable. Regular analysis in bioavailability, quality control, and bioequivalence investigations of biological matrices may be effectively performed using the established approach.