Cefuroxime Axetil Tablets
Action and use
Cephalosporin antibacterial.
Definition
Cefuroxime Axetil Tablets contain Cefuroxime Axetil. They may be coated.
Content of cefuroxime, C16H16N4O8S
92.5 to 105.0% of the stated amount.
Identification
Tests
Related substances
Carry out the method for liquid chromatography, Appendix III D, using solutions (1) to (3) described under Assay.
The chromatographic conditions described under Assay may be used.
The requirements stated under Assay apply.
In the chromatogram obtained with solution (1):
the sum of the areas of the pair of peaks corresponding to the E-isomers in the chromatogram obtained with solution (3) is not greater than 1.5% by normalisation;
the sum of the areas of any peaks corresponding to the Δ3-isomers in the chromatogram obtained with solution (2) is not greater than 2.0% by normalisation;
the area of any other secondary peak is not greater than 1.0% by normalisation.
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
Calculate the total content of cefuroxime axetil, C16H16N4O8S, in the medium from the absorbances obtained and using the declared content of C20H22N4O10S in cefuroxime axetil BPCRS. Each mg of C20H22N4O10S is equivalent to 0.8313 mg of C16H16N4O8S.
Assay
Carry out the method for liquid chromatography, Appendix III D, using the following solutions. The solutions should be used immediately or stored in the dark at a temperature of 2° to 8° before analysis.
38 volumes of methanol and 62 volumes of 0.2m ammonium dihydrogen orthophosphate.
When the chromatograms are recorded under the prescribed conditions the retention times relative to cefuroxime axetil diastereoisomer A are approximately 0.9 for cefuroxime axetil diastereoisomer B, 1.2 for the cefuroxime axetil Δ3-isomers and 1.7 and 2.1 for the E-isomers.
The Assay is not valid unless:
in the chromatogram obtained with solution (2), the resolution factor between the peaks due to cefuroxime axetil diastereoisomer A and the cefuroxime axetil Δ3-isomer is at least 1.5 (if necessary, adjust the composition of the mobile phase);
in the chromatogram obtained with solution (4), the resolution factor between the peaks corresponding to cefuroxime axetil diastereoisomers A and B is at least 1.5 (if necessary, adjust the composition of the mobile phase).
Calculate the content of C16H16N4O8S as the sum of the areas of the two peaks corresponding to diastereoisomers A and B of cefuroxime axetil and using the declared content of C20H22N4O10S in cefuroxime axetil BPCRS. Each mg of C20H22N4O10S is equivalent to 0.8313 mg of C16H16N4O8S.
Labelling
The quantity of active ingredient is stated in terms of the equivalent amount of cefuroxime.