Comprehensive Method Development for High-Throughput Quantification of Ursodoxycholic Acid Using ۲D-LC-MS/MS

This paper details the development of a high-throughput analytical method for the quantification of Ursodoxycholic Acid (UDCA) in plasma samples using a two-dimensional liquid chromatography tandem mass spectrometry (۲D-LC-MS/MS) system. The innovative approach integrates an autosampler with precise timing to direct analyte flows through two chromatographic columns for enhanced separation. Electrospray ionization in negative mode facilitated sensitive detection, while calibration achieved robust quantification across a wide dynamic range (۵۰–۸۰۰۰ ppb). Method validation was conducted as per ICH guidelines, demonstrating exceptional performance metrics, including intra-day precision (RSD < ۵%), accuracy (recovery > ۹۵%), and stability under various storage conditions. The study provides a streamlined methodology for pharmaceutical analysis and regulatory compliance, ensuring reliable detection of UDCA in clinical studies.

کلیدواژه ها:

Ursodoxycholic Acid ، high-throughput analysis ، ۲D-LC-MS/MS ، analytical method validation ، dynamic range ، plasma quantification