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Fast analysis of related impurities of Cefpodoxime Proxetil USP 43 monograph method as per USP modernization criteria

Instrument Type: UHPLC

The Thermo Scientific Vanquish Flex UHPLC system is applied for the chromatographic purity analysis of Cefpodoxime Proxetil. The results obtained for the resolution between the peaks due to S-epimer and R-epimer was 4.5 (USP criteria of minimum 4.0) and theoretical plates for R-epimer were 25,623 (USP criteria of minimum 19,000). By modernizing an older USP monograph after the regulation provided in USP General Chapter <621>, the run time can be reduced by 64% and solvent consumption can be lowered by almost 74% by simply migrating to a 3µm column.

Related Substances analysis of Telmisartan and Amlodipine Besylate tablets using a C18 HPLC column

Instrument Type: UHPLC

The Thermo Scientific Vanquish Flex Binary UHPLC system is applied for the related substances analysis of Telmisartan and Amlodipine Besylate tablets. The analysis was performed on a Thermo Scientific Acclaim RSLC 120 C18 column. The separation results and peak asymmetry were satisfactory.

Related substances analysis of sumatriptan succinate using a mixed-mode HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of the related substances of sumatriptan succinate. The analysis was performed on a Thermo Scientific Acclaim Mixed-Mode WCX-1 HPLC column. The separation results and peak asymmetry were satisfactory.

Separation of related impurities of Romiplostim by Reverse Phase chromatography using a wide pore phenyl column.

Instrument Type: HPLC (Biocompatible)

The Thermo Scientific Dionex UltiMate 3000 LC Bio-LC system equipped with a column pre-heater is applied for the Reverse phase analysis of Romiplostim. The separation was performed on a Thermo Scientific MAbPac RP column with UV detection at 280 nm.

Composition and related substances analysis of colistin sulfate using a C18 HPLC column as per EP 8.4 monograph method

Instrument Type: HPLC

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.