ICH Q2(R1)-GUIDED VALIDATION OF ANORMAL PHASE HPLC UV METHOD FOR THIRAM IN TECHNICAL WP FORMULATIONS COMPLYING WITH SANCO QC STANDARDS

To develop and validate a robust normal phase HPLC UV method for quantifying thiram in its formulations, ensuring it meets validation criteria defined in ICH Q2(R1) and residue limits specified by SANCO (SANCO/12571/2013 rev.3).Silica-based normal-phase column with an optimized mixture of non polar protic solvents (e.g., hexane/isopropanol) delivering strong retention and sharp UV-detectable peaks. UV detection set at thirams max (typically 230 254nm), optimized during method development.Thiram extracted from the 80% WP matrix via solvent extraction and centrifugation, followed by clean-up to minimize matrix interferences.Verified by injecting blank (solvent), placebo (matrix without API), spiked sample, and reference standard confirming no co-eluting peaks at thirams retention time; peak purity confirmed via UV spectral matching.