Analytical profile of raw material and finished product of cefuroxime axetil.

ABSTRACT

Cefuroxime Axetil is the 1-acetoxyethyl ester of Cefuroxime. Chemically cefuroxime axetil is (RS)-1-hydroxyethyl (6R, 7R)-7-[2-(2-furyl) glyoxyl-amido]- 3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo-Oct-2-ene-2-carboxylate, 72-(Z)-(O-me-thyl-oxime), 1-acetate-3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. The cefuroxime raw material was identified by HPLC and IR Spectroscopy. The sample is tested for the solubility, diastereoisomer ratio, crystallinity and bulk density. The amount of cefuroxime axetil was estimated by HPLC assay method. The Cefuroxime axetil finished product was identified by HPLC and IR Spectroscopy. The average weight of tablets was calculated by taking the weights of 20 tablets. The content uniformity of the dosage units was calculated by weight variation method. The dissolution rate was calculated by HPLC method by using Paddle apparatus. The amount of Cefuroxime present in the sample was estimated by HPLC assay method. The known and unknown related substances present in the compound were estimated by HPLC method. Results obtained during the study were satisfactory and can be used for commercial purpose.