The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the organic impurities analysis of Sulfacetamide Sodium. The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the USP 39 monograph. The results obtained for resolution, tailing factor and %RSD met the criteria stated in the USP. The results obtained for resolution between sulfacetamide and sulfanilamide was 21 (USP criteria of NLT 5.0), tailing factor for sulfacetamide was 0.98 (USP criteria of NMT 1.5) and %RSD for sulfacetamide was 1.0% (USP criteria of NMT 2.0%).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for assay analysis of sulfacetamide Sodium. The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the USP 39 monograph. The results obtained for tailing factor and %RSD met the criteria stated in the USP. The results obtained for the tailing factor for sulfacetamide was 0.94 (USP criteria was 0.9 to 1.8) and %RSD for sulfacetamide was 0.1% (USP criteria was NMT 0.5%).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the related substances analysis of Sulfacetamide Sodium. The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the EP 8.0. The results obtained for resolution met the criteria stated in the EP. The results obtained for resolution between the peaks due to Impurity A and sulfacetamide was 14.5 (EP criteria of minimum 5.0).

The Thermo Scientific HPLC system is applied for the analysis of sulfa drugs. The separation is performed using a Thermo Scientific Acclaim PolarAdvantage column, with UV detection at 254 nm.

A fast and reliable separation for quality control of small molecule drug candidates is demonstrated using Thermo Scientific Accucore aQ HPLC columns. The method run time was 3.25 minutes with each compound adequately resolved. The excellent peak shape was maintained for more than 11000 injections.