Stability testing of cefuroxime in tablets by micellar liquid chromatography

Abstract

Cefuroxime is a broad-spectrum second-generation bactericidal cephalosporin antibiotic active against beta-lactamose-producing strains. Anti-cefuroxime, the geometric isomer of cefuroxime, might be present in cefuroxime dosage forms as a process-related impurity and possible degradation product. In the work discussed in this paper a precise and sensitive micellar liquid chromatographic (MLC) method for stability testing of cefuroxime axetil and anti-cefuroxime axetil in tablets, using benzoic acid as internal standard, was developed and validated. MLC was performed on an XTerra C-18 reversed-phase column at 50 degreesC with 8:92 (v/v) acetonitrile-20 mm sodium dodecyl sulphate, pH 2.5, as mobile phase at a flow rate of 1.5 mL min(-1). Detection was at 280 nm. Under these conditions the retention time and retention factor were of 6.65 min and 4.57, respectively, for cefuroxime axetil and 11.45 min and 8.59, respectively, for anti-cefuroxime axetil, indicating that the compounds were well separated. RSD values for quantification of cefuroxime axetil and anti-cefuroxime axetil were 0.39 and 1.7%, respectively, indicating the precision of the MLC method was good. The method is sensitive-LOD = 0.5 mug mL(-1) and LOQ = 1.5 mug mL(-1) for anti-cefuroxime axetil-and reproducible, with good recovery values.