The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the composition and related substances analysis of Colistin Sulfate. The analysis was performed on a Thermo Scientific Acclaim 120 C18 HPLC column using the method described in the EP-8.4 monograph. The results obtained for peak resolution met the criteria stated in the EP.

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay and organic impurities analysis of Tetracycline. The analysis was performed on a Thermo Scientific Acclaim Polar Advantage II C18 HPLC column using the method described in the USP 39 monograph. The results obtained for peak resolution exceed the criteria stated in the USP. Resolution between epitetracycline and tetracycline was 6.5 (USP criteria of NLT 2.5) and anhydrotetracycline and 4-epianhydrotetracycline was 8.7 (USP criteria of NLT 2.5). The tailing for tetracycline was 1.0 (USP criteria of NMT 1.5)

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the related substances analysis of Sulfamethoxazole. The analysis was performed on a Thermo Scientific Syncronis C8 HPLC column using the method described in the EP-8.0 monograph. The results obtained for peak resolution and relative retention times exceeded the criteria stated in the EP. Resolution between sulfamethoxazole and Impurity-A was 5.7 (EP criteria of not less than 3.5).

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%).