An Lc-Ms/Ms Method Development and Validation for the Quantification of Lurbinectedin in Biological Matrices; Application to Kinetic Study in Rabbits
TL;DR
The findings regarding accuracy, specificity, sensitivity, matrix effect, recovery and stability findings of Lurbinectedin in plasma samples for the established method highlight its significance in bioequivalence and pharmacokinetic studies.
Abstract
Objective: The primary objective of the present research was to develop an accurate liquid chromatography and tandem mass spectrometry (LC-MS/MS) technique utilizing electrospray ionization for the quantification of Lurbinectedin in biological matrices. Methods: The components were isolated using chromatographic techniques on a Hypersil Gold (50 mm×4.6 mm, 5µ) C18 column. The volume of injection was established at 5μl. The column oven temperature and flow rate were maintained at 25 °C and 0.50 ml/min, respectively. Isocratic method of separation was executed with a mobile phase composition of formic acid (0.1%), acetonitrile, and methanol in a ratio of 10:20:70 (%v/v/v). Results: In the context of multiple reaction monitoring, the observed fragments and product ions findings were recorded at m/z 785.28/174.09 for Lurbinectedin and 450.11→257.10 for the Asciminib internal standard. The linearity graph for the drug exhibited an r2 value exceeding 0.99 and demonstrated a rectilinear relationship across the concentrations in between 0.01 and 200ng/ml. Precision findings within a single day ranged from %RSD of 3.12% to 4.85%, while across different experimental days, precision values varied between 2.96% and 5.01%. The average Lurbinectedin recoveries ranged between 93.83% to 102.36% at three quality control levels. Conclusion: The findings regarding accuracy, specificity, sensitivity, matrix effect, recovery and stability findings of Lurbinectedin in plasma samples for the established method highlight its significance in bioequivalence and pharmacokinetic studies.