A simple, robust LC-MS/MS assay for quantifying cefuroxime in human plasma was developed. Cefuroxime and tazobactam,\nas internal standard (IS), were extracted from human plasma by methanol to precipitate protein. Separation was achieved on a\nZorbax SB-Aq (4.6 Ã?â?? 250 mm, 5 ?m) column under isocratic conditions. The calibration curve was linear in the concentration\nrange of 0.0525ââ?¬â??21.0 ?g/mL (r = 0.9998). The accuracy was higher than 90.92%, while the intra- and interday precision were\nless than 6.26%. The extraction procedure provides recovery ranged from 89.44% to 92.32%, for both analyte and IS. Finally, the\nmethod was successfully applied to a bioequivalence study of a single 500mg dose of cefuroxime axetil in 22 healthy Chinese male\nsubjects under fasting condition. Bioequivalence was determined by calculating 90%Cls for the ratios of Cmax, AUC0??, andAUC0??\nvalues for the test and reference products, using logarithmic transformed data.The 90% Cls for the ratios of Cmax (91.4%?104.2%),\nAUC0?? (97.4%?110.9%), and AUC0?? (97.6%?111.1%) values were within the predetermined range. It was concluded that the two\nformulations (test for capsule, reference for tablet) analyzed were bioequivalent in terms of rate and extent of absorption and the\nmethod met the principle of quick and easy clinical analysis.
Loading....