The stability of Cefuroxime axetil in tablets.

The stability of cefuroxime axetil in BIORACEF tablets was studied by means of long term (298 K/60% RH), intermediate (303 K/65% RH), accelerated (313 K/75% RH) and stress stability tests. Changes in the concentration of cefuroxime axetil diastereoisomers A and B and their total was determined using the RP-HPLC method, as described in a monograph of Cefuroxime axetil tablets in the British Pharmacopoeia 2003. After 2 years of storage under long term, 1 year under intermediate and 6 months under accelerated storage conditions, the preparation of BIORACEF meets the quality requirements as regards both. the active substance content and chromatographic purity. Under stress conditions the decomposition of cefuroxime axetil diastereoisomers follows the first-order reversible autocatalytic reaction with delta3-isomers of cefuroxime axetil as the main product. The kinetic parameters of the decomposition reaction were calculated and compared with analogical parameters obtained for ZINNAT tablets stored in the same conditions.