A Validated LC-MS/MS Method for the Determination of Sulindac and Its Metabolite Su-EP‑C in Human Plasma and Their Pharmacokinetic Application in Healthy Volunteers.

ABSTRACT: A rapid, specific, and sensitive LC-MS/MS method for the determination of sulindac and its metabolite Su-EP-C in human EDTA-K2 plasma was developed. The method was fully validated using sulindac-d3 and Su-EP-C-d3 as internal standards. Separation was performed on a Kinetex C18 analytical column (100 Å, 50 × 2.1 mm, 5 μm). MPA consisted of 0.05% formic acid (FA) in water, while MPB comprised 0.05% FA in ACN. The flow rate was maintained at 0.300 mL/min, and the injection volume was 3 μL. Mass spectrometry conditions: ESI, positive mode, MRM. The linear range of detection was from 60.00 to 24,000.00 ng/mL for sulindac and from 30.00 to 12,000.00 ng/mL for Su-EP-C. The intra- and interbatch accuracy deviations of sulindac ranged from -5.1 to 5.0%, and the intra- and interbatch precision range

SUBMITTER: Lou T 

PROVIDER: S-EPMC12676308 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature