Abstract
A simple, robust LC-MS/MS assay for quantifying cefuroxime in human plasma was developed. Cefuroxime and tazobactam, as internal standard (IS), were extracted from human plasma by methanol to precipitate protein. Separation was achieved on a Zorbax SB-Aq (4.6 × 250 mm, 5 μm) column under isocratic conditions. The calibration curve was linear in the concentration range of 0.0525–21.0 μg/mL (r = 0.9998). The accuracy was higher than 90.92%, while the intra- and interday precision were less than 6.26%. The extraction procedure provides recovery ranged from 89.44% to 92.32%, for both analyte and IS. Finally, the method was successfully applied to a bioequivalence study of a single 500 mg dose of cefuroxime axetil in 22 healthy Chinese male subjects under fasting condition. Bioequivalence was determined by calculating 90% Cls for the ratios of C max, AUC0−t, and AUC0−∞ values for the test and reference products, using logarithmic transformed data. The 90% Cls for the ratios of C max (91.4%~104.2%), AUC0−t (97.4%~110.9%), and AUC0−∞ (97.6%~111.1%) values were within the predetermined range. It was concluded that the two formulations (test for capsule, reference for tablet) analyzed were bioequivalent in terms of rate and extent of absorption and the method met the principle of quick and easy clinical analysis.
Highlights
Cefuroxime is a second-generation cephalosporin used against a variety of infections
Speaking, using LCMS technique for quantification in biofluids, internal standard (IS) should have similar physical, chemical, and chromatographic properties as the analyte [11]. In this literature, the retention time of cefuroxime and IS was far apart, as 8 min and 4.4 min, respectively. It could not compensate for the sample losses that might occur during the sample preparation and chromatographic steps as well as for matrix effects under certain conditions
Stationary phase, the composition of mobile phase, and column temperature were investigated in the LC domain, so as to achieve optimal peak shape and good separation from the void volume
Summary
Cefuroxime is a second-generation cephalosporin used against a variety of infections. Speaking, using LCMS technique for quantification in biofluids, IS should have similar physical, chemical, and chromatographic properties as the analyte (ideally eluted at similar retention time) [11] In this literature, the retention time of cefuroxime and IS was far apart, as 8 min and 4.4 min, respectively. We designed a sensitive and robust LC-MS/MS method following simple protein precipitation extraction with tazobactam as IS for determination of cefuroxime in human plasma. This method was accurate, sensitive, robust, and simple and was successfully applied to a bioequivalence study of a single 500 mg dose of cefuroxime axetil formulations (test and reference) in 22 healthy Chinese male subjects under fasting condition. -MS2 (298.90) CE (−18): 0.101 min from Sample 9
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