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Assay analysis of Albuterol Sulphate as per USP 40 Monograph

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for Assay analysis of Albuterol sulphate as per USP. The analysis was performed on a Thermo Scientific Hypersil Gold CN HPLC column using the method described in the USP 40 monograph. The results obtained for resolution met the criteria as per USP. The results obtained for the resolution between Albuterol sulphate & Albuterol Impurity A was 4.26 (USP criteria is NLT 1.5). RSD for replicate injections were found to be 0.68 & 1.14 forAlbuterol sulphate & Albuterol Impurity A respectively (USP criteria is NLT 1.5%).

Assay analysis of Amoxicillin and Clavulanate Potassium as per USP

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of Amoxicillin and Clavulanate Assay as per USP. The analysis was performed on a Thermo Scientific Syncronis aQ L1 HPLC column using the method described in the USP 40 monograph. The results obtained were found to be within acceptance criteria as stated in the USP. Resolution between Amoxicillin and clavulanic acid was 14.0 (USP criteria: not less than 3.5). Tailing Factors observed were 0.84 & 1.25 respectively (USP criteria: not more than 1.5 for each analyte). RSD found to be less than 2% for both analytes

Assay & organic impurities analysis of Cefixime by USP 39 monograph method using Syncronis C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of assay and organic impurities for Cefixime as per the USP 39 monograph. The analysis was performed on a Thermo Scientific Syncronis C18 HPLC column using the method described in the USP 39 monograph. The results obtained for resolution met the criteria as per USP. The results obtained for the resolution between Cefixime & Cefixime (E)-isomer was 2.32 (USP criteria is NLT 2.0). Column efficiency was found to be >4500 (USP criteria - NLT 4000 theoretical plates).