Abstrakt

Determination of residual formic acid in ceftazidime drug substances using ion chromatography by facile non-suppressed conductivity detection

RamalingamMurugan, S.Sriman Narayanan

A simple and sensitive ion chromatographic method, for the determination of residual formic acid in sterile ceftazidime drug substance has been developed and validated. The formate ion was separated from the drug substance by an acid selective ion exchange column. The mobile phase was 10% acetone and 90% of aqueous sulfuric acid (5 10-4 M). This method was linear over the concentration in the range of 0.25g/ml to 25.33g/ml with r2> 0.98 and the signal-to-noise ratio 0.065. Thismethod was validated in terms of Selectivity, Linearity, Precision,Accuracy, Robustness, Limit of detection (LOD), Limit of quantitation (LOQ). This method has been succefully applied for formulated and drug substance of ceftazidime.