Green UHPLC approach for the quantitative determination of tiopronin residues in cleaning validation processes.

ABSTRACT: This study presents the development and validation of a novel reverse-phase ultra-high-performance liquid chromatography (UHPLC) method for quantifying tiopronin residues on manufacturing equipment surfaces as part of cleaning validation. Tiopronin, a synthetic thiol compound with therapeutic applications, requires stringent manufacturing controls to ensure product safety and efficacy. Existing analytical techniques mainly focus on quantifying tiopronin in pharmaceutical formulations or biological matrices. However, no methods specifically address cleaning validation for tiopronin production equipment. Using an Analytical Quality by Design approach, this UHPLC method was optimized and validated by ICH Q2 (R2) guidelines. The technique employs a Waters ACQUITY UPLC H-Class PLUS C-18 column

SUBMITTER: Gohel J 

PROVIDER: S-EPMC12553291 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature