Optimising LC-ESI-MS/MS
for Quantitation and Pharmacokinetics of Sodium Phenylbutyrate and Taurursodiol
in Rat Plasma
Maddala Sandhya Madhuri and Parimi Ravi
Res. J. Chem. Environ.; Vol. 29(11); 81-91;
doi: https://doi.org/10.25303/2911rjce081091; (2025)
Abstract
This study developed and validated a novel LC-ESIMS/ MS method for quantifying sodium
phenylbutyrate (SPB) and taurursodiol (TSD) in rat plasma. Analytes were extracted
via solvent extraction and separated using a Waters X-Bridge BEH phenyl-functionalized
column (150 mm × 4.6 mm, 3.5 μm) with a mobile phase of acetonitrile and 0.1% trifluoroacetic
acid in water (30:70 v/v). The method achieved separation within 5 minutes at a
1 ml/min flow rate, with SPB and TSD retention times of 2.227 and 3.333 minutes
respectively. Quantitation was performed using MRM in positive ionisation mode with
nitrogen as the collision gas, monitoring specific ion transitions.
Linearity was observed for TSD (10–200 ppb) and SPB (30–600 ppb), with recoveries
of 96.98–98.57% (TSD) and 95.22–98.59% (SPB). Intraday precision (%CV) ranged from
0.39–1.91% (SPB) and 0.85–9.03% (TSD). Pharmacokinetic parameters such as Cmax,
tmax, AUC0−∞ and half-life were successfully determined. The method met FDA and
EMA validation criteria, demonstrating accuracy, precision and stability. It is
suitable for pharmacokinetic studies and quality control offering a reliable, reproducible
and efficient tool for routine SPB and TSD analysis.
