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EP 8.0 monograph - impurity determination of ofloxacin using a C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of ofloxacin and its impurities. The separation was performed on a Thermo Scientific Syncronis C18 HPLC column using the method described in the EP 8.0 monograph. The results obtained for resolution exceeded the criteria stated in the EP. Resolution between impurity E and ofloxacin was 3.3 (EP criteria of not less than 2.0).

Separation of ciprofloxacin and ofloxacin using the Chinese Pharmacopeia methodology

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 system is applied for the separation of ciprofloxacin and ofloxacin. This was achieved using a Thermo Scientific Acclaim 120 C18 column with UV detection at 278 nm following the method in the Chinese Pharmacopeia. The resolution obtained between ciprofloxacin and ofloxacin was 2.38, which exceeds the specification of greater than 1.5 stated in the pharmacopeia.

An improved separation of Ofloxacin, Ciprofloxacin and impurities using a Thermo Scientific Acclaim 120 C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex Ultimate 3000 system is applied for the separation of ofloxacin, ciprofloxacin and impurities. This was achieved using a Thermo Scientific Acclaim 120 C18 column with UV detection at 294 nm.