Application of Multiple Reaction Monitoring in ۲D -LC-MS/MS for the Simultaneous Quantification of UDCA and Internal Standards in Clinical Plasma Samples

This research focuses on the optimization and implementation of multiple reaction monitoring (MRM) in a ۲D -LC-MS/MS system for the simultaneous quantification of Ursodox ycholic Acid (UDCA) and Valsartan (internal standard) in plasma samples. The analytical system incorporates dual chromatographic columns and electrospray ionization in negative mode, ensuring high specificity and sensitivity. The optimized chromatographic conditions, employing ۰.۲% formic acid and acetonitrile as mobile phases, achieved a total run time of less than ۴ minutes. Calibration curves spanning ۵۰ – ۸۰۰۰ ppb revealed excellent linearity, with a detection limit of ۵۰ ppb. Validation adhered to EMEA and ICH M۱۰ guidelines, confirming the method’s accuracy (۹۸ –۱۰۲%), precision (RSD < ۵%), and negligible matrix effects (MEF > ۹۰%). Application to clinical samples demonstrated the method’s efficacy in high -throughput analysis, paving the way for broader a doption in pharmacokinetic and bioavailability studies. This study highlights the capability of MRM -enabled ۲D -LC-MS/MS in delivering precise quantification of plasma biomarkers.

کلیدواژه ها:

MRM ، Ursodoxycholic Acid ، Valsartan ، ۲D -LC-MS/MS ، analytical chemistry ، pharmacokinetics ، plasma biomarkers