Assay and organic impurities analysis of Lorazepam as per USP method using Syncronis C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of Lorazepam and its Organic impurities as per its USP method. The analysis was performed on a Thermo Scientific Syncronis C18 L1 HPLC column using the method described in the USP 39 monograph. The results obtained were found to be within acceptance criteria as stated in the USP. Resolution between Lorazepam Rel Comp A and Lorazepam Rel Comp E was 2.55 (USP criteria of not less than 2.0). Tailing Factor for Lorazepam standard solution was found to be 0.95 (USP criteria of not more than 2.0).

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).

USP 39 monograph - Organic impurities analysis of Cefdinir using a C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the organic impurities analysis of cefdinir. The analysis was performed on a Thermo Scientific Acclaim 120 C18 HPLC column using the method described in the USP 39 monograph. The results obtained for resolution and %RSD met the criteria stated in the USP 39. The resolution between cefdinir and the third peak of cefdinir related compound A was 3.1 (USP criteria of NLT 1.5) and %RSD for cefdinir was 0.1% (USP criteria of NMT 2.0%).