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Related substances analysis of cefotaxime sodium using a polar end-capped C18 HPLC column as per EP 8.0 monograph method

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the related substances analysis of Cefotaxime 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 and symmetry factor met the criteria stated in the EP. The results obtained for resolution between the peaks due to Impurity E and Cefotaxime was 6.7 (EP criteria of minimum 3.5) and asymmetry factor for cefotaxime was 1.1 (EP criteria of maximum 2).

Assay and related substances analysis of Cefotaxime sodium using a C18 HPLC column as per JP XVI and KP X monograph methods

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay and related substances analysis of Cefotaxime Sodium. The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the JP XVI/KP X. The results obtained for resolution and symmetry factor met the criteria stated in the JP/KP. The results obtained for resolution between the peaks due to desacetyl Cefotaxime and Cefotaxime was 32.8(JP/KP criteria of minimum 20.0) and symmetry factor for cefotaxime was 1.0 (JP/KP criteria of maximum 2).

Organic impurities analysis of Cefotaxime using a C18 HPLC column following USP 39 monograph (procedure 2)

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the organic impurities (procedure 2) analysis of Cefotaxime Sodium. The analysis was performed on a Thermo Scientific Syncronis C18 HPLC column using the method described in the USP 39. The results obtained for resolution and tailing factor met the criteria stated in the USP. The results obtained for resolution between the peaks due to Cefotaxime and Cefotaxime related compound E was 13.6(USP criteria of minimum 4.0) and tailing factor for cefotaxime (10 µg/mL) was 1.0 (USP criteria of maximum 2).

Assay and organic impurities analysis of Cefotaxime sodium using a C18 HPLC column using USP 39 monograph - (procedure 1)

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay and organic impurities (procedure 1) analysis of Cefotaxime Sodium. The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the USP 39. The results obtained for resolution and tailing factor met the criteria stated in the USP. The results obtained for resolution between the peaks due to cefetamet and Cefotaxime related compound E was 8.9 (USP criteria of minimum 1.5) and tailing factor for cefotaxime was 1.4 (USP criteria of maximum 2).

EP 8.0 monograph - impurity determination of cefalexin by reversed-phase HPLC-UV

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of cefalexin and its impurities. The separation was performed on a Thermo Scientific Hypersil Gold HPLC column using the method described in the EP 8.0 monograph. The results obtained for resolution and tailing factor exceeded the criteria stated in the EP. Resolution between impurity A and B was 5.4 (EP criteria of not less than 2.0). Resolution between cefalexin and cefatoxim was 6.8 (EP criteria of not less than 1.5).